Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Oral Fluid Specimen Testing for Drugs
Federal RegisterMay 2, 2023
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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;
ODAPCwebmail@dot.gov.
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;
drugabatement@faa.gov
). 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:
bryan.price@dot.gov
). 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:
gerald.powers@dot.gov
). 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:
iyon.rosario@dot.gov
).
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
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, § 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 §§ 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 § 40.187(e) because there
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 § 40.67 (direct observation collections) and § 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 § 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 § 40.209, “a test is
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 § 40.209(b)(3) to add a reference to § 40.35 for oral fluid collector training, in addition to the existing reference to § 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 §§ 40.13(c) and (e) (now §§ 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
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 § 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 § 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
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 allows the collection to be done by any oral fluid collector qualified under part 40—either an external contractor or an employee the DOT-regulated employer dispatches to the scene of the accident or incident. In addition, offering both urine and oral fluid testing would permit an employer and its service agent to efficiently deal with situations when an employee cannot provide a sufficient specimen. Finally, having the flexibility of both options allows an employer and its service agent the ability to perform a directly observed collection as an oral fluid test, without concerns about the gender of the observer.
Understanding Windows of Detection
As discussed earlier, like urine testing, oral fluid testing is scientifically accurate and forensically defensible. As our scientific authority for drug testing under OTETA, HHS has determined that oral fluid testing, set at the cutoffs established by HHS, meets the requirements for accurate Federal drug testing.
Urine and oral fluid specimen testing each offer different benefits and limitations in assisting employers in detecting and deterring illegal drug use, and no single specimen type is perfect for every situation. In an effort to assist employers in understanding some benefits and limitations to each methodology, we reviewed and referenced various scientific sources in compiling a table of the windows of detection. This table provided information regarding the specific timeframe in which an oral fluid or a urine drug test could identify the presence of the drugs for which we test. We asked for public comment on the accuracy and completeness of the information in the windows of detection table we provided.
We received a few public comments on the actual information in the table. A couple of commenters believed that the windows of detection we had listed for oral fluid testing were too long. Several commenters suggested that we remove the table from the final rule, saying that it caused confusion. Another commenter cautioned that windows of detection should be interpreted carefully because the results depend on study design and context. They noted that the window of detection “for a single dose may differ from those observed in individuals who are regular users. In addition, route of administration has significant impact on concentrations and detection of drugs in oral fluid over time.” That commenter, a laboratory, also noted, “in general, detection windows in oral fluid are shorter than those in urine, but it should not be inferred that the cutoffs are equivalent”. Another laboratory cautioned against including a windows of detection table in the final rule because “the
Federal Register
is not updated each time a new scientific reference becomes available that may or may not support the duration and literature referenced was very limited and not very recently published.” Quest Diagnostics discussed the complexity in understanding windows of detection due to “numerous variables in play including: drug dose, drug purity, route of administration, time since dosing, individual metabolic rate variability and hydration state (for urine).” As the study of oral fluid continues, Quest Diagnostics noted “more data will be forthcoming as oral fluid testing is instituted across the United States that will provide more detailed information about oral fluid detection windows which will make these stated detection windows obsolete and likely misleading.”
Many commenters relied on the shorter windows of detection for oral fluid testing listed in the table from the preamble to the NPRM to reach the assumption that oral fluid test results are more akin to impairment tests. That is not a correct assumption. While oral fluid testing may provide a better indicator of an employee's recent use of the drug, it also detects frequent users. Furthermore, there is no definitive drug impairment test. Importantly, the DOT testing program is a deterrence-based program to prevent illegal drug use, not an impairment testing program.
We agree with the commenters who cautioned against including a windows of detection table in the final rule. Any information that is accurate today in a table of windows of detection may not be accurate shortly thereafter, as oral fluid testing is deployed by DOT-regulated employers and related research on the windows of detection continues. For the reasons stated above, we have removed the windows of detection table and we note that oral fluid windows of detection will likely be shorter than for urine. Employers, working in conjunction with their service agents, should determine whether urine or oral fluid collection is best for their program and in what contexts.
Substance Abuse Professional Issues
For more than twenty years, part 40 has been clear that all evaluations with a Substance Abuse Professional (SAP) must be face-to-face and in-person. During the COVID-19 public health emergency, we realized conducting face-to-face in-person evaluations may not be possible or advisable for certain individuals. As a result, the Department issued a notice of enforcement discretion on April 4, 2020, to allow SAPs to conduct, for a specified period of time, what we called “face-to-face remote evaluations”. We extended that notice several times from 2020-2022, and on December 20, 2022, we extended the notice to remain in effect until the effective date of this final rule. (
https://www.transportation.gov/odapc/Statement_of_Enforcement_Discretion_SAPs
)
To make a remote evaluation as effective as possible, within the notice of enforcement discretion we provided, we said the technology the SAP uses should permit a real-time two-way audio and visual communication and interaction between the SAP and the employee. We said the SAP should determine if the quality of the technology (
e.g.,
speed of the internet connection, clarity of the display, application being used, etc.) is sufficient for the SAP to gather all the visual (
e.g.,
non-verbal physical cues) and audible information you would normally observe in an in-person face-to-face interaction. In other words, the SAP must be able to objectively evaluate verbal, non-verbal and physical characteristics to a sufficient extent through the chosen technology. We added that SAPs should document the format of the assessment in the final
SAP report. We also stated we would not consider a remote evaluation to be an act of serious noncompliance meriting resort to the Public Interest Exclusion (PIE) process.
We proposed amendments to several sections of subpart O of part 40 to make the notice of enforcement discretion permanent. We proposed and are adopting modifications to § 40.291(a)(1) to allow the SAP to conduct the evaluations either in-person or remotely, with criteria based on those from the COVID-19 notice as conditions for remote evaluations. First, the revisions require the technology used to permit real-time two-way audio and visual interaction between the SAP and the employee (
i.e.,
a conversation without video would not meet this criterion). Second, the quality of the technology (
e.g.,
speed of the internet connection, clarity of the display) must be sufficient to allow the SAP to gather all the visual and audible information the SAP would normally observe in a face-to-face in-person interaction. In addition, the technology must incorporate sufficiently robust security to protect the confidentiality of the conversation. Third, a SAP can only use the technology in question if the SAP's State-issued license authorizes the SAP to do so (
e.g.,
a State license may permit a practitioner to work only with clients in the State of licensure).
On a second but related topic, we asked for public comment about whether a SAP's respective “qualifying credential” (
i.e.,
State license or other credential under § 40.281) would allow them to evaluate individuals who live in a different State from where the SAP is licensed. We asked if this was already allowed, especially since virtual video evaluations are often done outside of the DOT-regulated context. We also asked for public comment about what steps a SAP, who is remotely evaluating an individual outside of the SAP's locality, could take to ensure a working knowledge of quality programs and qualified counselors available to the employee when recommending a course of treatment and/or education.
The comments we received on SAP remote evaluations and crossing “State lines” were thought-provoking and abundant. There were many supporting, opposing, qualifying and suggesting improvements to the proposals. We will discuss them in-depth.
Regarding remote SAP evaluations, the majority of commenters enthusiastically supported the proposal. Many commenters who identified themselves as qualified SAPs who have practiced for years said remote evaluations offered unforeseen benefits. Several said they had learned to use technology to better study the employee's mannerisms, facial expressions, and nonverbal cues as effectively as they could for their in-person consultations. One SAP admitted to not being receptive to remote evaluations before the COVID-19 public health emergency, but acknowledged that “everything has changed, including people's receptivity to virtual interactions . . . even extensive treatment is often virtual.” That same SAP acknowledged reading comments from other SAPs who do not support virtual evaluations, but strongly disagreed with those fellow commenters because of the advances in telehealth and the skills SAPs are developing for evaluating clients virtually as effectively as in-person. Specifically, this SAP and many others recognized that they had built skill in assessing eye movement, involuntary body twitches, and other aspects of nonverbal indicators that are key to accurate and complete evaluations. One SAP pointed out there would be no difference between a virtual and an in-person evaluation if the technology is “sufficient to allow the SAP to gather all visual and audible information that would be apparent in a face-to-face interaction.” One commenter wanted DOT to gather more information on the effectiveness of remote evaluations, believing the SAP will miss too many details if the evaluation is not conducted in-person. However, with the advances in telehealth and the robust comments by the many SAPs who took the time to comment, we believe that we have reliable information from practicing SAPs who are confident that face-to-face remote evaluations are as effective as in-person face-to-face evaluations.
In addition, several practicing SAPs said they learn more about the employee and circumstances in virtual assessments in the home of the employee, because the SAP can “speak to family members and obtain other collateral information that is not always readily available in the office setting.” Some said that the employees seem to be more relaxed and communicative when they can participate from the comfort of their home. Several SAPs believed it is less stressful for employees in remote areas to be able to see a SAP without having to travel to the SAP's office. Many SAPs expressed gratitude about the reduction in cost to the employees, who often needed to travel significant distances to see the SAP in-person. Several SAPs said that this innovation that arose temporarily during 2020-2022 should be finalized because it created access to evaluation for many employees who were at a loss for where to go to seek help, especially for those who live in remote rural areas.
Some SAPs mentioned multiple “safety” factors as a reason to allow remote evaluations. One said, “If someone has been removed from safety-sensitive duties . . . meeting remotely keeps them off the road further lessening the potential for harm to the public.” Another SAP pointed out that, after an employee was “drinking and driving, does it really make sense to say `hey I know you were under the influence while driving, but can you get in your car and come see me?’ ” Some of the SAPs said that there are occasional personal safety issues with employees who are angry because of their non-negative results or refusals. One commenter who has been involved with SAP evaluations and training for more than 30 years said, “virtual assessments have increased personal safety for SAPs dealing with belligerent employees.” Multiple SAP commenters noted the personal safety issues are significantly lessened when the contact between the employee and the SAP can be conducted virtually.
A number of SAPs noted a reduction in cost for themselves. Although there was an initial cost of setting up the details for conducting remote evaluations generally (
e.g.,
subscribing to HIPAA-compliant software platforms, obtaining the right equipment for audio and visual interactions), the costs of not needing to conduct evaluations in a formal office setting was a significant cost savings. One SAP asked if we could allow post office boxes for the SAP's address because many SAPs no longer maintain a professional office space outside their home.
Regarding the use of a post office box instead of a physical address, we will not consider that change at this time. While many SAPs conduct a significant number of evaluations virtually, we are still maintaining the option for in-person evaluations. In some situations, in-person evaluations may be the best choice and we want to ensure that SAPs consider that. Also, having a physical location where DOT can inspect, audit, or investigate a SAP and their records is important, and we require this of service agents in part 40. If the SAP chooses to run their operations from their home, they must furnish the address from that place of business on their letterhead. If using one's home address is not acceptable to an individual SAP, they must continue to provide a physical commercial location address for part 40 purposes.
In not allowing SAPs to use post office boxes, we are being consistent with our Question and Answer from September of 2001, which reads, in pertinent part, as follows: “May the MRO's address entered on the CCF be a post-office box number only? . . . No. The address must contain at least a number and street address. . . . The post-office box can be included, but not in lieu of the number and street address.”
https://www.transportation.gov/odapc/part40QA/40-311
We are also adding this reminder to § 40.40(c)(2), to note MRO addresses must not be simply a post office box.
The SAP commenters who favored allowing remote evaluations agreed the technology must provide real-time audio and visual interaction between the SAP and the employee. We agree that an audio call, alone, will not satisfy the requirements of part 40 or the expectations of these professionals.
Technology security concerns were on the mind of some commenters, also. Many SAPs suggested that we require a HIPAA-compliant software or platform for these audio-visual interactions. Commenters also recommended using high-level platforms to ensure confidentiality, and not merely commercial platforms that are available for video calls.
It is important to note that HIPAA does not apply to the DOT testing, which involves searches and seizures under the Fourth Amendment of the United States Constitution. However, we recognize SAPs may be required by the State that licenses the SAP to follow HIPAA as part of their clinical evaluations. While we will not require specific software and we will not reference HIPAA compliance as a criteria, we have specified in § 40.291(a)(1)(ii) of the final rule the performance standard that the technology must provide “security to protect the confidentiality of the communication.” We also added language to § 40.291 to explain that the technology needs to be at the expected level of confidentiality and security as is required for substance abuse evaluations. It is important to note that this is a performance standard. We did not prescribe exact measures, which may currently be appropriate, because those standards will change, and we want to ensure the most effective standards continue to be applied.
Often, the individual State's licensing and/or private credentialing authority set ethical and confidentiality criteria for licensed professionals who are performing their duties via virtual platforms. Some of the SAP commenters have noted that there are additional ethical guidelines and standards that they follow in order to provide remote evaluation services. Sometimes these additional requirements are set by the qualifying credential authorities, other times these are guidelines the SAPs follow because they are recommended by the professional organizations with which they affiliate. We urge SAPs to continue to follow their respective codes of ethics and confidentiality. The ethics of using video technology is an evolving field, and we expect SAPs to keep up with their ethical requirements as this aspect of their profession continues to improve and evolve.
One SAP suggested that we make telehealth education part of SAP training. We will not require that because not all SAPs will offer remote evaluations. Also, SAP training should continue to focus upon part 40 requirements and not about generally how to practice more effectively.
SAPs who opposed the proposal varied in wanting to see remote evaluations prohibited versus allowed in special circumstances. Some commenters only wanted to see remote evaluations when there is a pandemic, while others would support remote evaluations in a national crisis or in situations where the employee was located hundreds of miles from the nearest SAP. Other SAPs disliked remote evaluations because “paperwork and payment” are better collected in person. Some SAP commenters were concerned about employees “shopping for less expensive SAPs” outside their own high-cost zip code. Conversely, one commenter who favored the remote evaluation option said that this reduction in cost for the out-of-work employee was exactly why the Department should allow an employee to seek a SAP outside their home area. Also, SAPs who opposed remote evaluations said it would be difficult to find qualified and appropriate treatment resources outside the SAP's local area, while other SAPs said this would not be a problem because of the ability to search for treatment resources on the internet. Those SAPs who suggested using the internet also said the SAP would then call the treatment facility to establish communication and determine if the treatment resource was appropriate for the employee's needs.
One employer's association provided a reply to other commenters who wanted the SAP to justify why a remote evaluation is being held instead of an in-person evaluation. The employer's association recommended allowing the SAP to choose remote or in-person without the need to justify one over the other “because `DOT cannot predict and codify the wide range of circumstances that could reasonably justify remote SAP evaluation, nor could employers effectively determine whether a particular circumstance is appropriate if the DOT applies an ambiguous standard, like `extraordinary circumstances'.” Reply comments such as this are very helpful to us as regulators, and we thank this commenter and others who took the time to read and respond to the comments of others.
Commenters who favored and those who opposed the proposal were almost unanimous in wanting in-person evaluations to continue as an option. That option should be decided by the SAP, many of the commenters said.
We had proposed and agree with allowing SAPs the option of choosing to conduct face-to-face evaluations remotely in lieu of in-person meetings, and never proposed for the in-person evaluations to be eliminated. We have decided to adopt the proposed provision with minor modifications. We agree with the commenters and will permit both evaluations in-person or via virtual technology meeting the requirements of part 40. The choice of which option to use will be the decision of the SAP, without any need to justify the use of one or the other.
With SAPs being permitted to conduct remote evaluations, we anticipated the issue of SAPs providing evaluations across State lines would be something we needed to address. On this subject, we received a few favorable comments, but most commenters disagreed with the Department taking action in this area.
Some commenters had no objections to a SAP providing part 40 services outside the State in which the SAP is licensed. One of these commenters noted the MROs are licensed in one State but are permitted to provide MRO services under part 40 in all 50 States, the U.S. Territories, Canada and Mexico. Other commenters said they had no objections to allowing SAPs to practice across State lines, as long as part 40 clarified that the SAP could specifically do so as a qualified SAP under part 40. Some told us their certifications as “national” or “international” drug and alcohol counselors, which they received through larger organizations that administer the SAP examinations, already allow them to practice throughout the United States. Also, several commenters, who are practicing SAPs, told us their licensing States already allowed them to practice across State lines. Consequently, within the parameters of their own State's licensure, they have been conducting
SAP evaluations of DOT-regulated employees for approximately two years. Another SAP told us the licensure from their State “does not permit me to conduct assessments across state lines, however, I have an additional certification for telemental health (BC-TMH). Together, my credentials permit me to practice both counseling and my SAP assessments remotely.” One commenter asserted that “SAP is a federal qualification and I believe we should be permitted by federal designation to see a DOT-governed employee from anywhere.” Another commenter stated, “As a federal program, drug testing requirements for transportation workers already span jurisdictions; it follows that an SAP should likewise be able to conduct evaluations across jurisdictions . . .” An MRO association characterized the SAP as “not a treatment provider, just as the MRO is not a treatment provider for donors. . . . Thus, performing a substance abuse assessment and recommending treatment and a plan, the SAP would unlikely be in violation of any state practice act.”
The commenters who opposed allowing practice across State lines said there was value in State licensing and overseeing counselors who provide services to individuals within the State. Others who disfavored the proposal raised the argument addressed above about a distant SAP not knowing the treatment facilities that offer the appropriate treatment for an individual employee.
The commenters have made it clear that there is much confusion about whether a SAP can practice across State lines. It is also clear that this is an evolving topic, having nothing to do with part 40. The States, individually, are addressing needs that have arisen during the past two years and the resulting evolution of telehealth options. The SAP certification organizations (
see
§ 40.283) should make their own determinations about whether those individuals who hold their respective qualifying credential can practice throughout the United States. SAPs should continue to keep informed about the permissions and jurisdictional limitations of their qualifying credentials. If a State licensing authority or DOT-recognized credentialing organization decides that it is appropriate for one or more of their authorized practitioner categories that qualifies a person to be a SAP to practice across State lines, DOT will defer to that granting authority.
With that said, in the short-term, the current inconsistency as to where a SAP can practice remotely is creating problems for some DOT-regulated employees who are seeking SAP services. With an in-person SAP evaluation, the employee sits in the SAP's own office, and there is no question that the SAP is licensed to practice in their own office. Unique to a remote SAP evaluation, an employee may not be located in the same geographic jurisdiction where the SAP is authorized to practice, thereby making the SAP's underlying qualifying credential not valid for that particular evaluation. Under the DOT COVID-19 notice allowing remote evaluations, we stated: “You may only utilize the technology if your State-issued license authorizes you to do so and within the parameters of that authority.” Consequently, any SAP who evaluates an employee outside the parameters of the SAP's State-issued license or other credential is acting without authority and violating part 40. To address this, we have added a new § 40.281(f) to create a limitation on an otherwise qualified SAP under this part who conducts evaluations outside the geographic limitations applicable to their credential.
Some otherwise qualified SAPs have acted outside their authority and created problems for employees who received evaluations under the DOT COVID-19 notice. When we have learned that a qualified SAP evaluated an employee outside the SAP's authorized geographic jurisdiction, we have asked the employee to seek the services of a different SAP who is qualified and can conduct the evaluation as permitted by their credential. There has been no other option under part 40 until this final rule.
However, we acknowledge the costs of having an out-of-work employee seek and pay for a second SAP evaluation is an unfair and unintended consequence of allowing remote evaluations. Therefore, we are adding a new § 40.297(c) to notify the otherwise qualified SAP (
see
§ 40.281(a) through (d)) that they must not perform evaluations outside the geographic jurisdiction of their credential(s). If the SAP who made the evaluation exceeds their geographic jurisdiction, the employee will not be required to seek the evaluation of a second SAP. The evaluation and assessment of the SAP is still valid for the employee, even if the SAP has failed to follow § 40.297(c) by exceeding their geographic jurisdiction. The employer must carry out the follow-up testing plan of the SAP, even though the SAP was acting outside their geographic jurisdiction. We have added a new § 40.303(d) to let employers know they can utilize such evaluations and follow-up plans, if they choose to return the employee to work. We believe that these new sections, along with new § 40.281(f), address the unintended consequences of costs and stress to employees.
The new §§ 40.281(f) and 40.297(c) also require that a qualified SAP must not evaluate any employee outside the jurisdiction in which the SAP can practice. In other words, the intention is to prohibit the SAP from crossing geographic lines without authority and to relieve the employee from the need to pay the cost of seeking a new SAP evaluation. If the SAP engages in evaluations outside the limits of their credential, then this activity could constitute serious noncompliance and the SAP could be subject to a PIE.
Finally, as a compliance reminder: Every SAP is expected to be aware of the specific requirements of their State or credentialing authority and may not be authorized to practice across State lines. Some of the SAPs who commented that they have national and international credentials through certain organizations may not be correct and should check with those organizations who, previously, have told us their credentials are not nationwide. It will benefit both the SAP and every DOT-regulated employee they evaluate to know what their geographic jurisdiction is.
Using Identification Numbers Other Than a Social Security Number or Employee Identification Number
Since the inception of the DOT's drug testing program, the Federal Drug Testing Custody and Control Form (CCF) has included a space for the Social Security Number or Employee Identification Number (SSN or Employee ID No.). We proposed to add a new definition for “SSN or Employee ID No.”, and some minor changes to rule language that mentioned “SSN” in §§ 40.14, 40.45, 40.97, 40.163, and 40.311. The rationale for the change includes privacy concerns and identity theft considerations that arose over the years since the 1988 inception of part 40. Also prompting these amendments was a final rule in 2016, in which the Federal Motor Carrier Safety Administration (FMCSA) changed the information Commercial Driver's License (CDL) holders and Commercial Learner's Permit (CLP) holders must provide on the CCF and Alcohol Testing Form (ATF). Specifically, in 2016, FMCSA amended 49 CFR 382.123(a) and (b) to require FMCSA-regulated drivers undergoing DOT-regulated testing and their employers to use the CDL number and State of issuance,
instead of the SSN or other employee ID number, on the CCF and ATF for all drug and alcohol tests conducted under 49 CFR part 382 (part 382). See FMCSA's Commercial Driver's License Drug and Alcohol Clearinghouse (Clearinghouse) final rule (81 FR 87686; Dec. 5, 2016). 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 the Pipeline and Hazardous Materials Safety Administration (PHMSA) or FTA).
To address the concerns about using SSNs and to conform to the existing requirement for CDL numbers to be used for employees regulated by FMCSA, we proposed changing the provisions of part 40 requiring the use of the employee's SSN or an employee ID number. We proposed a definition of the term “SSN or Employee ID No.” in § 40.3, as well as amendments to sections pertaining to the CCF and/or the Alcohol Testing Form (ATF), and in SAP reports. We proposed to require CDL numbers for FMCSA-regulated employees, for consistency with part 382. We proposed to add that identification numbers issued by States or the Federal government would also be allowed for employees not regulated by the FMCSA.
We received several public comments on this issue. The majority of those commenters favored allowing alternate identification numbers, citing concerns about the employee's security, privacy, and wanting to protect employees from potential identity theft. Some commenters suggested we only allow the last four digits of the SSN to be used. Those opposed to the proposed changes thought the only modification to part 40 should be to allow FMCSA-regulated employees to use their CDL numbers. Those commenters thought allowing others to use their driver's license number would result in violations unrelated to FMCSA-required testing erroneously being reported to the FMCSA's Clearinghouse. Finally, some of the commenters asked what to do when presented with a form of identification that has “expired”.
Switching to using the last four digits of the SSN would not resolve the concerns about privacy and identity fraud adequately because some part of the SSN would still be used. In addition, for laboratories that receive thousands, and in some cases tens of thousands, of CCFs each day, it is not uncommon for those labs to receive multiple CCFs with the same last four digits.
We acknowledge the concerns about violations being incorrectly entered into the FMCSA Clearinghouse if an employee who is not regulated by the FMCSA provides their driver's license number. Some States use the same number format for a CDL as for any private driver's license number issued by the State. In some States, the CDL holder does not have a separate private license for driving their own car—only the CDL is issued. However, the essence of the concern is not so much about the number being used as it is about the entry of incorrect data into the FMCSA's Clearinghouse by program participants.
We have weighed the various considerations raised by the commenters and have adopted the proposed language in each section because the confusion the commenters are concerned about can be addressed with the program participants who may incorrectly enter data into the FMCSA's Clearinghouse. We will not remove the option for an employee to provide their SSN because that specific term currently appears on the CCF. In the future, if that term is ever removed from the CCF, which belongs to HHS, we would consider amending these part 40 provisions to exclude the SSN.
The new definition “SSN or Employee No.” will allow a collector, MRO, SAP, Breath Alcohol Technician (BAT), Screening Test Technician (STT) or other service agent or employer to utilize only the CDL number and State of issuance for FMCSA-regulated drivers tested under part 382, and to allow the CDL number to be used as an option on tests conducted under the authority of the other DOT agencies. The definition also allows any other State- or federally issued identification number to fulfill the part 40 requirement for a unique identification number.
Since States often do not differentiate between CDL numbers and private driver's license numbers, we will continue to remind employers and collectors to be very specific about the exact DOT agency regulation under which the employee will be tested. An employer directly, or through its service agent, must check the block for the “Specific DOT Agency” on Step 1.D. of the CCF. The name of each agency is provided in Step 1.D. (
i.e.,
FMCSA, FAA, FRA, FTA, PHMSA, USCG). When the employer sends the employee to the collection site, the employer must be clear with the collector as to what specific DOT agency regulates the test, as required by § 40.14(g). The collector, in turn, is expected to ensure that the correct DOT agency is checked, unless the employer has already checked the box. If unsure, without delaying conducting the actual test, the collector should contact the employer to ask what specific DOT agency regulates the test. Checking the correct block in Step 1.D.'s “Specific DOT Agency” block is as important as checking the correct box for the “Reason for Test” in Step 1.E. Employers and collectors are, and should be, aware that not knowing the correct reason for the test may subject an employee wrongfully to a direct observation collection or may fail to ensure that an employee is subject to a direct observation when they need to be observed. Similarly, checking the wrong box in Step 1.D. will have potentially incorrect consequences if the employee has a non-negative result. We will continue to educate and remind employers and collectors to appreciate the need for identifying the correct DOT agency on the testing form.
If an employee is wrongfully identified as an FMCSA-regulated employee during the collection process, the MRO is likely to discover this in the verification interview for a non-negative result. For example, during the verification interview some MROs simply ask the employee what they do for the employer. In any case, if the MRO finds the FMCSA box was incorrectly checked, the MRO must not report the verified non-negative result to the FMCSA's Clearinghouse. The only employees whose results are ever reported to the FMCSA's Clearinghouse are those employees who have taken an FMCSA-regulated test.
Similarly, if the employer is determining whether or not a collection site refusal has taken place and finds that the FMCSA box was incorrectly checked, the employer must not report the refusal to the FMCSA's Clearinghouse. Since only the employer or the MRO can enter a violation into the FMCSA's Clearinghouse, these are the only program participants who can correct their own entries, including when they have incorrectly identified an employee as an FMCSA-regulated individual when they are not.
Finally, we recognize the issue of employees using expired forms of identification at the collection site has been an ongoing problem. As we have advised for several years, we want collectors to know it is acceptable to accept an expired photo ID issued by a Federal, State, or local government agency, if the ID has not been expired for more than 1 year. This information is contained in the current Office of Drug and Alcohol (ODAPC) Urine Collection Guidelines and will be added to the ODAPC Oral Fluid Specimen Collection Guidelines.
Medical Review Officer Reversal of Test Cancellations
In part 40, there are many instances where an MRO would cancel a drug test result. These are set forth in § 40.133 (when verifying an invalid result without a donor interview), § 40.145 (if there is a legitimate explanation for an adulterated or substituted result), § 40.159 (for various specific explanations for an invalid result), § 40.161 (after laboratory rejection of a fatal flaw or an uncorrected flaw); § 40.187 (if a split fails to reconfirm or bottle B is unavailable for testing); § 40.191 (if there is a refusal to go for a medical examination where there is no contingent offer of employment on a pre-employment test); § 40.193 (where there is an acceptable medical explanation for an insufficient specimen); § 40.195 (if a medical examination reveals clinical evidence of drug use), and § 40.199 (after the laboratory reports a fatal flaw). We did not propose any of these types of cancellations as grounds for reversing a cancelled test.
Instead, the proposal addressed situations where a test is cancelled due to paperwork errors, which would be correctable flaws, but which were not corrected before the MRO sent the cancellation to the employer. Those are specifically found in §§ 40.203 and 40.205. In the preamble to the NPRM and in the proposed regulatory language of § 40.207(d), we gave the example of the MRO reversing the cancellation of a test where the missing or delayed paperwork is subsequently found and provided to the MRO. We also said that we did not intend for MROs to reverse the cancellation of a test that was rejected for testing by a laboratory.
There were several comments on this proposal. The commenters supportive of the proposal understood this as an administrative fix to allow an MRO to uncancel a test result involving a correctible error the MRO decided was not timely corrected. Many of those who opposed the proposal were concerned about DOT allowing MROs to reverse cancellations that were related to the fairness and accuracy of the test. Those were not the intended cancelled tests subject to the proposed change. Even so, we understand the questions in the preamble for public comment could have led commenters to conclude otherwise. The comments received have helped to shape a better final rule for this provision, which we have adopted with modifications.
Some MROs and other service agents said they already thought MROs could reverse a cancelled test. They did not see a need for a change because reversing cancelled tests was already part of their MRO practice. It is for exactly this reason we needed to consider modifying the regulation because these MROs had no authority to reverse cancellations. Throughout the history of part 40, there has not been a regulatory provision that allows an MRO to “uncancel” a test that the MRO has cancelled. We proposed a new paragraph § 40.207(d) to allow an MRO to reverse the cancellation of a test in very specific and limited circumstances.
The American Trucking Association supported the change as a useful “administrative fix” that would save money for random tests. They gave a solid example of the impact of the problem when they said: “the employee is sent for a random test; the paperwork for the collection site is lost, so the MRO cancels the test; the paperwork is recovered, and the test is counted toward the employer's random testing requirement.” As such, the proposal is a “rational administrative fix that will not have a detrimental impact on safety . . . to address situations in which administrative errors require a driver to retake a drug test unnecessarily.”
The Association of American Railroads and American Short Line and Regional Railroad Association supported the proposal. They said this “proposed amendment would be helpful in situations where an employer requires a negative result (
e.g.,
a pre-employment, return-to-duty or follow-up test), and would avoid the burdens and inconvenience of requiring an employee to travel for, or otherwise accommodate a test, more than once.”
Several consortia/third party administrators (C/TPAs) agreed with the proposal. One C/TPA referred to “circumstances that missing paperwork is located after the MRO has cancelled the result. This would allow the MRO to then report the result.” To illustrate the benefits of the proposal, the commenter described a frequently occurring scenario they encounter: “a delay in receiving information that was inadvertently omitted from the custody and control form. In these situations, if the test has already been cancelled, a driver must be sent back to the collection facility to provide a new sample constituting a significant additional cost for motor carriers and drivers. Allowing un-cancelling of tests is a commonsense solution to an unintended consequence.”
Some who supported the proposal wanted the Department to ensure it would be used in narrow circumstances. They supported reversals of cancellations only in tests cancelled for administrative errors that are correctible flaws. We added language to the final rule, in the form of a parenthetical, to note correctible flaws arising under §§ 40.203 and 40.205 would be examples of what is reversible.
Several commenters, including the National Drug and Alcohol Screening Association (NDASA), C/TPAs, collector trainers, and a transit agency noted an existing issue within part 40: an MRO cannot cancel a test without having Copy 1 and Copy 2 of the CCF in the MRO's possession, per §§ 40.129(b), 40.161(a) and (c). These commenters said, if the reason the MRO is cancelling the test is because the CCF paperwork is missing, then part 40 should allow the MRO to cancel the test without holding either or both Copies 1 and 2 of the CCF. One commenter recommended we allow the MRO to cancel the test by noting on the bottom of Copy 1 that Copy 2 is missing. Another commenter suggested allowing the “MRO to issue a report that the test is cancelled if the MRO has not received a legible [CCF].”
In response to the concerns from these commenters about an MRO's inability to cancel a test without the proper paperwork, we have made changes to part 40. In § 40.129(b), as a logical outgrowth of the comments, we have struck the words “test cancelled” so that cancelled tests do not require both Copies 1 and 2, as the other verified non-negative results listed would require. We have modified §§ 40.161(a) and (c) to allow an MRO to use either copy or to issue a report, if Copy 1, Copy 2, or both are missing. Also, we have made a technical amendment to insert quotation marks around “rejected for testing” and the word “laboratory” in § 40.161(c). As in §§ 40.127(c)(1) and 40.129(b)(1), we remind the MRO of the obligation to try to obtain Copy 2 or any other CCF copy containing the employee's signature before cancelling a test. If a copy of the CCF with the employee's signature cannot be obtained, then the MRO can use the report format set forth in § 40.163(c)(1) through (9).
The commenters who opposed the proposal to allow an MRO to uncancel a test included organized labor (
e.g.,
the Transportation Trades Department (TDD), the Airline Pilots Association (ALPA), and the National Air Traffic Controllers Union), Quest Diagnostics, and others. One commenter thought this would affect so few tests that it was not worth doing. Another opposing commenter objected to allowing laboratories to cancel tests and requested that the proposal restrict the MROs to a 30-day window for reversing a cancelled test. Another commenter
said the proposal will “undermine the finality of these MRO administrative determinations, and raise practical concerns with undoing such actions.” That commenter also wanted DOT to create a process for appealing MRO decisions, which is outside the scope of this rulemaking. One commenter said the proposal “could in effect increase the frequency of drug testing beyond what is reasonable and justified. We are also concerned that it would create administrative burdens to the employees being tested who would not have the same finality they currently have if a test is canceled.” Another commenter was concerned that, “If an individual is told the test is cancelled, they may decide not to take steps to protect themselves (that they would otherwise have done had they been notified of an `uncancelled' test), only to later learn that the test has been `uncancelled'.”
We see no reason to limit the MRO's reversal to 30 days, but have maintained the proposed requirement for an MRO to consult ODAPC if the reversal of the cancellation occurs more than 60 days after the test was cancelled. We do not have exact data on the number of cancelled tests this will impact each year because, as we said earlier and the commenters supported, many MROs were already reversing cancellations because they mistakenly thought they had this authority.
Quite often the cancellations occur when an MRO is unable to get the information needed from the collection site. Often, MROs cannot reach the collector. Sometimes, the MROs must contact a general call center and wait days, or longer, to reach the collector who did not send the needed paperwork (
i.e.,
Copy 2 or a memorandum of correction). This delay in reaching the collector should be eliminated by the change to § 40.40 to require the collector to provide the telephone number where they can be reached more directly and promptly. Ensuring the MROs and their staffs have timely access to the collectors is likely to result in fewer cancellations. So, this is effectively a two-pronged approach to addressing the cancellation problem.
Allowing an MRO to reverse a result cancelled for administrative reasons will not increase the frequency of drug testing because there currently are many reasons an employee may be called back for a second test when an MRO cancels a test. Also, reversing the cancellation of a test would not reduce the finality of an employee's expectations because, if a second test is needed because of the reversal of the cancellation, an employee would not necessarily know if and when to expect a second test. Examples of this include when a split specimen is lost or damaged, then the employee must come back in for another test; or when a laboratory reports an invalid result and the MRO tells the employee to report for another collection. At times, if a negative result is needed (
i.e.,
pre-employment, return-to-duty, or follow-up), a cancelled test actually causes an employee to return for an unanticipated second test. This final rule will reduce the instances of those second tests.
An employee must make themselves available for an additional test when the employer directs them to go. Thus, the finality of a test has never been tied to the employee's expectations.
As for the concern that an employee “may decide not to take steps to protect themselves”, we respectfully submit that the employee would not lose the right to have a split specimen tested or to request a litigation hold on the actual urine specimen. We hope this information eases that concern.
Another industry association and a C/TPA opposed the proposal because the employer may perform another test after the first is cancelled on a pre-employment, return-to-duty or follow-up test. On a similar note, another commenter said “the ability to `un-cancel' a test will cause significant confusion, particularly for those cases where a negative result is required (
e.g.,
for a pre-employment test) and the donor has likely already submitted to a second test.” To avoid this problem, some commenters suggested only allowing an MRO to uncancel a test when the “cancelled test did not qualify for recollection, [then] the MRO should have the option to invoke the same consultation requirement we have in [§ ] 40.149(a)(4).”
We believe part 40 already addresses these concerns. In a test where a negative result is not required (
i.e.,
random, reasonable cause/suspicion, or post-accident), the employer has no authority to send the employee for a second test after the first test is cancelled, unless the result of the first test was cancelled due to an invalid result. In a test where a negative test result is required (
i.e.,
pre-employment, return-to-duty, or follow-up), the employee should have been sent for a second test after the cancellation. Under § 40.162, an MRO is provided clear directions for handling multiple verified results for the same testing event, which the MRO can apply to reconciling a second test result with the reversed cancellation.
In the proposal, we 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. This is the same consultation requirement we have in § 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. We received several supportive comments on this part of the proposal and have finalized it, as proposed.
V. Section-by-Section Analysis
The Department made a deliberate decision not to create a separate subpart of part 40 or to designate another part of Title 49 of the United States Code to house oral fluid testing. Since many of the provisions of part 40 can be applied to urine, oral fluid and other potential future testing matrices, we proposed to integrate new provisions concerning oral fluid testing within the current part 40 structure. In other sections, we proposed to revise current sections and their titles to specify they would only apply to urine testing.
§ 40.3 What do the terms used in this part mean?
We proposed to delete the definition of “screening drug test” because the term is not used in part 40. For consistency with HHS terminology, we have removed the defined term “invalid drug test” in the definitions section, § 40.3, and have updated the wording in the definition of “invalid result” to be consistent with the current language in the HHS mandatory guidelines for both urine and oral fluid. We have also updated §§ 40.123(c) and 40.129(a) and (d) to use the term “invalid result”.
To harmonize part 40 with the HHS Guidelines and to update part 40, we have added seven defined terms. We have added “alternate specimen” as an authorized specimen of a type other than the one previously collected (
e.g.,
in a case where the initial collection was urine, oral fluid would be an alternate specimen). “Cutoff” is the quantitative point distinguishing a need for further testing or whether a laboratory result, for example, is 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 have added definitions for “oral fluid specimen” and “urine specimen.” We have added a sentence to the definition of “oral fluid specimen” to explicitly state that an oral fluid collection is a direct observation collection. “Specimen” is the generic term for any fluid, breath or material collected from someone for a
drug or alcohol test. We have added “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). For the reasons explained in the Principal Policy section, we added a new definition for “SSN or Employee ID No.”.
We have modified seventeen definitions in § 40.3. For the most part, the changes are not substantive, and conform part 40's wording with that of the HHS guidelines. For example, “collection container” refers to vessels used in all collections, whether of urine or oral fluid. In the definition of “specimen bottle,” we added that the term could include “tube” or “vial” used in oral fluid testing.
One commenter requested we change the definition of “split specimen” to allow two separate specimen collections. This would be inconsistent with OTETA's requirement for a single specimen to be collected from and subdivided in the presence of the tested individual. Thus, we have adopted the proposed definition of “split specimen” with no changes.
Most of the comments were supportive of the proposed changes. Thus, we have adopted the proposed changes to § 40.3.
§ 40.13 How do DOT drug and alcohol tests relate to non-DOT tests?
The Department has made minor changes to paragraphs (b), (c), and (d) of this section for clarification in the context of oral fluid testing. For example, paragraph (d) is applicable only to urine testing, since oral fluid testing is not part of the normal medical examination procedure to which the paragraph applies.
We have redesignated the current paragraphs (e) and (f) as new paragraphs (f) and (g). We have added a new paragraph (e) to specify that a drug or alcohol test administered as directed by a medical examiner, exclusively as part of a medical examination required for an employee to qualify for a certificate or license, is not a DOT drug or alcohol test under part 40 and related DOT agency drug and alcohol testing rules. For example, if a certified medical examiner decided to give a motor carrier driver a drug test as part of an examination for medical card purposes, that would be a “non-DOT test.” An employer could request a required DOT pre-employment test be conducted when the medical examination is being conducted, as currently permitted under 49 U.S.C. 31306(d).
We have added a new paragraph (h) to further emphasize that DOT drug and alcohol tests are authorized to be conducted only on safety-sensitive employees as designated in the agency drug and alcohol testing regulations. DOT-regulated tests must not be conducted on non-regulated persons (
i.e.,
those who do not perform DOT-regulated safety-sensitive duties). DOT testing is a legal warrantless search and seizure permitted by the Fourth Amendment of the Constitution and is only applicable to regulated persons. The DOT's strong interest in maintaining transportation safety, when weighed against an individual's right to privacy, allows DOT's regulated testing to pass Constitutional scrutiny. See
Bluestein
v.
Skinner,
908 F.2d 451 (9th Cir. 1990);
Skinner
v.
Railway Labor Executives' Assn.,
489 U.S. 682 (1989);
Treasury Employees
v.
Von Raab,
489 U.S. 656 (1989). There is no Federal transportation safety interest in using this testing for individuals other than safety-sensitive employees. Consequently, DOT testing cannot be conducted on employees not regulated by the DOT agencies. Companies do not have the authority to conduct DOT-regulated testing on non-regulated employees. DOT regulations also do not allow non-DOT testing to satisfy an employer's obligation to meet its minimal annual random testing rate for DOT testing.
Some individual commenters supported the proposed modifications to paragraphs (d), (e), and (f). Other commenters noting the changes to § 40.13 were also supportive. We have finalized the proposed changes.
§ 40.14 What information must employers provide to collectors?
We received one comment in support of the modification we proposed to § 40.14(b). We have adopted this change to add clarity and to recognize that, in the motor carrier industry, FMCSA requires the CDL to be used for purposes of the Drug and Alcohol Clearinghouse (Clearinghouse) (
see
49 CFR 382.705).
We have adopted our proposal to add a new paragraph (k) for “the specimen type to be collected”. We had proposed to add paragraph (l) to specify if a urine test is to be directly observed. Although there were no comments on paragraphs (k) and (l), we have decided to remove the proposed paragraph (l) because it is redundant with current paragraph (i).
§ 40.21 May an employer stand down an employee before the MRO has completed the verification process?
Under part 40 and the corresponding DOT agency regulations, an employer can request a waiver to “stand down” an employee from performing safety-sensitive functions based on a laboratory confirmed non-negative result (
i.e.,
positive, adulterated, substituted or any combination thereof) until the MRO issues the employer a verified result. The authority to stand down an employee is very limited and requires an employer to obtain an actual waiver from the DOT agency before implementing a stand down policy.
As with any laboratory-confirmed positive, the MRO may verify the final result as negative (
e.g.,
if an employee offers a legitimate medical explanation such as a legal prescription). We proposed to add a new paragraph (c)(2)(vii)(C) of this section to prevent the employer to send an employee back in for another test using a different specimen type after receiving a verified negative result. We did not want the employer to order a second test using a different methodology to see if the window of detection could later impact the result. If the MRO cancelled the test (
e.g.,
per the requirements of § 40.159), then the employer can send an employee in for an alternate specimen collection.
We received one comment on this proposal. The combined commenter, a C/TPA and MRO practice, asked us to clarify in the final rule preamble that this applies to more than laboratory positives. Specifically, it also applies to laboratory-confirmed adulterated and substituted results. We have made this distinction in the preamble, as it already exists in § 40.21(b). Other than making this change, we have finalized the changes as proposed.
§ 40.23 What actions do employers take after receiving verified test results?
We proposed minor changes in this section to account for the use of oral fluid or urine in the event of an invalid specimen. In § 40.23(f), we proposed flexibility in allowing the subsequent direct observation collection to either be an oral fluid collection or a urine collection under direct observation. In paragraphs (f)(1) and (5), we offered language to acknowledge a urine collection would need to be directly observed. As written, it is clear oral fluid collections are directly observed.
We received two comments. One commenter supported allowing the employer to choose an alternate specimen type for the directly observed collection. The other commenter said an employee could deliberately cause their urine test to be invalid, then refrain from drug use for a few days and test negative on an oral fluid test. This commenter was concerned employees
would use the windows of detection for the different methodologies to their advantage.
While we recognize the concern of the second commenter, we want to emphasize that oral fluid is a scientifically valid form of testing for the DOT-regulated drug testing program. Our program is deterrence-based. With established cutoffs, we do not seek to detect the presence of every drug, we only seek to detect drugs at their cutoffs and deter illegal drug use. Since HHS has determined oral fluid testing is scientifically viable and forensically defensible, we are willing to leave it to the determination of the individual employers to select the methodology acceptable to them under given circumstances. For this reason, we encourage employers to look at all aspects of using urine drug testing versus oral fluid drug testing as their choice for a particular test, in accordance with part 40.
In consideration of the comments and for the reasons set forth above, we have finalized the proposed changes to § 40.23.
§ 40.25 Must an employer check on the drug and alcohol testing record of employees it is intending to use to perform safety-sensitive duties?
Beginning January 6, 2020, FMCSA implemented its Clearinghouse regulation, set forth in part 382, subpart G. As part of those requirements, FMCSA-regulated employers with drivers subject to the drug and alcohol use and testing regulations set forth in part 382 to query the Clearinghouse drug and alcohol database for information about an employee's past drug and alcohol violations that occurred while the driver was employed by another FMCSA-regulated employer. The Clearinghouse regulations apply only to employers and employees subject to the requirements of part 382.
Until January 2023, FMCSA-regulated employers had dual requirements. They had to conduct a pre-employment query of the Clearinghouse, as required by § 382.701(a), and continue to follow the procedure of § 40.25, as set forth in § 382.413, to request a prospective employee's drug and alcohol violation information from previous DOT-regulated employers.
We have added § 40.25(a)(2) to reflect that, beginning January 6, 2023, the requirements changed for FMCSA-regulated employers, who now must rely solely on querying the Clearinghouse, in accordance with § 382.413(b), to determine whether an applicant violated FMCSA's drug and alcohol testing regulations while employed by other FMCSA-regulated employers. For example, after January 6, 2023, a motor carrier vetting a prospective employee is required to check the Clearinghouse to determine whether the driver's previous FMCSA-regulated employer(s) reported drug and alcohol testing program violations by that driver.
However, since the Clearinghouse does not include drug and alcohol violations committed by employees of other DOT agency-regulated employers, FMCSA-regulated employers must continue to comply with the requirements of § 40.25 when hiring an employee who has been employed by another DOT agency-regulated employer.
Under the new § 40.25(a)(3), we remind FMCSA-regulated employers to request the information about the employee listed in paragraph (b)-(j) of this section from any other DOT agency-regulated employer for whom the employee previously worked, if the employee was subject to another DOT agency's drug and alcohol testing program. If an applicant's past employment was with an employer regulated by, for example, the FTA or the FAA, the gaining motor carrier employer must continue to comply with the requirements of § 40.25 by requesting the required information directly from those employers, in accordance with § 382.413(c). This is necessary since drug or alcohol violations incurred while the driver was employed by a DOT agency other than FMCSA will not have been recorded in the Clearinghouse.
Although FMCSA-regulated employers must query the Clearinghouse for an employee's drug and alcohol testing information, employers regulated by the other DOT agencies do not have access to the Clearinghouse but must find out this important safety information for employees who previously worked for motor carriers. For example, if an FAA-regulated employer sends a § 40.25 inquiry to a motor carrier, the motor carrier must respond to that inquiry in accordance with § 40.25(h). Thus, the Clearinghouse will address motor carrier inquiries, but each FMCSA-regulated employer is required to retain the records and be ready to respond to § 40.25 inquiries from other DOT-regulated employers.
We did not receive any substantive public comments on these changes, which merely conform to FMCSA's requirements. We have finalized the proposed changes.
§ 40.26 What form must an employer use to report Management Information System (MIS) data to a DOT Agency?
We proposed a simple editorial change, substituting a reference to appendix J for a reference to appendix H. This conforms to a re-designation of the appendix letters but would make no substantive changes to the section or form. We did not receive any public comments on this change. We have adopted this change as proposed.
§ 40.29 And Similar Sections
We proposed deleting several sections (§§ 40.29, 40.37, 40.113, 40.169, 40.189, 40.217, and 40.313), which listed other sections of part 40 touching on a given topic (
e.g.,
employer responsibilities in § 40.29). These lists of cross-references were intended to assist readers in finding other relevant information before part 40 was searchable electronically. In the more than 20 years since we placed these sections into part 40, electronic search tools have become sophisticated and ubiquitous, making these sections no longer necessary.
A small number of commenters said they liked these cross references, but the majority of commenters said that the cross-references have outlived their usefulness because of electronic search options. One commenter said, “Please continue to make decisions about organization of part 40 based on logic, without regard to previous editions of the rule. Those of us who look at it every day need to do our jobs and learn the new numbers.” Another commenter noted, “it would not be a burden if the cross referencing was removed because the titles of the Subparts clearly identify the subject matter and the title/s of the section/s under those Subparts are worded in the format of a question with the answers found in that section.”
Therefore, we have adopted the changes. We removed the cross-reference sections of §§ 40.29, 40.37, 40.113, 40.169, 40.189, 40.217, and 40.313, as proposed.
§§ 40.31 and 40.35—Collectors and Their Qualifications—
We have updated § 40.31 to include oral fluid collectors who can collect DOT drug testing specimens. We have added a new § 40.35 to separately specify the requirements for collectors of urine and oral fluid specimens, respectively. Adding this section required renumbering existing § 40.35 to become § 40.36. We have paralleled the new § 40.35 as closely as possible to our existing training requirements for urine specimen collectors in § 40.33. We have added language to parallel § 40.213(b) for training on the specific devices.
In addition, we have included a clarification for both urine and oral fluid collectors prohibiting relatives, close friends, and certain employees (
e.g.,
co-worker or immediate supervisor) from conducting collections. This is consistent with existing guidance in the Department's Urine Specimen Collection Guidelines. We received substantive public comment on these changes. Several comments supported the following proposed wording: “a collector must not be related to the employee being tested (
e.g.,
spouse, ex-spouse, relative) or a close personal friend.” Other commenters, including Quest Laboratories, NDASA, and the Substance Abuse Program Administrator's Association (SAPAA) agreed with the exact wording proposed. An aviation employer, Flight Safety International, said they thought the list of specific relationships listed is too limited and would prefer the following wording: “the collector shall have no conflict of interest with regard to the donor's result”.
On SAP commenter asked that we not allow supervisors or managers to serve as collectors. The Aircraft Mechanics Fraternal Association asked us to clarify whether management is included in the category of those prohibited from collecting a specimen. The Passenger Vessel Association supported the existing prohibition on collections by immediate supervisors in the current § 40.31(d) is sufficient. This commenter said: “While the limitations proposed in 49 CFR 40.31(d) are problematic for vessels that are often operated by a small number of crew members with a strict supervisor/subordinate organization, that same paragraph finishes with caveat `unless no other collector is available and you are allowed to do so under DOT Agency drug and alcohol regulations,'. . .”, which this commenter supported.
We agree with the Passenger Vessel Association and other commenters, who supported the wording of the newly renumbered § 40.31(d). We did not change this long-standing provision cautioning against collection by the immediate supervisor of the employee being tested, which is now found in § 40.31(d) (formerly in § 40.31(c)).
Regarding the qualifications for oral fluid collectors in § 40.35, those who commented generally supported the proposal and we have, therefore, adopted it as proposed. One C/TPA wanted to see training similar to urine specimen collectors plus completing the manufacturer's training for each oral fluid testing device the collector will use. A large C/TPA and MRO practice said all collectors should be trained and qualified to perform both oral fluid and urine testing, and device-specific training should come from the manufacturer. One commenter, who performs a large number of trainings annually, said we should look at this the way we view alcohol testing training, which means there needs to be comprehensive part 40 training plus device-specific training. One commenter suggested we call any qualified oral fluid collector a “Drug Screening Collector Technician (DSCT)” to be consistent with Breath Alcohol Technicians and Screening Test Technicians. This commenter also recommended having oral fluid collectors: join the ODAPC list serve; be trained to all steps of the CCF, and in problem collections, fatal flaws, and collection site integrity; undergo five error-free mock collections; and have a requirement to requalify every five years. Similarly, NDASA and several C/TPAs wanted oral fluid collector training to include all of the proposed training elements, which mirrored the urine collector training with additions specific to oral fluid collections. SAPAA also commented in favor of device-specific training. Several commenters said there should not be five error-free mock collections per device.
Regarding creating a model training course for oral fluid testing and urine testing similar to the one we have for alcohol testing, we did not propose to create and require such model courses in this rulemaking. However, we will take the requests of these commenters into consideration in formulating future guidance.
We asked for comment about who should be considered appropriate for monitoring the mock collections necessary to qualify an oral fluid collector. We modeled the criteria for the oral fluid monitor after what we have set for urine collections in § 40.33(c): one who has regularly conducted DOT drug test collections for a period of at least one year; has conducted collector training under this part for at least one year; or has successfully completed a “train the trainer” course. The commenters supported keeping the same requirements for the mock collection monitors for oral fluid as for urine. Several commenters noted it would be inadvisable for the Department to allow individuals who have been collecting only non-DOT specimens to automatically qualify to train oral fluid collectors under part 40 but did not provide a reason for their rationale. Other commenters asked if virtual training and virtual mock collections were permissible. Both have been allowed for urine collector initial training, error correction training and for requalification training. Consequently, both will be permitted for oral fluid collector initial training, error correction training and for requalification training.
One commenter asked about whether there must be two or three individuals involved in the mock proficiency demonstrations. Whether they are in-person or virtual, we have always required at least two individuals to interact during the mock collections, while a best business practice is to have a third person act as the donor, so that the trainee could have the experience of “collecting from an employee” without actually collecting a specimen during the training. We believe this is an extremely important requirement because collectors must deal with real people and real specimen collections. If the monitor and trainee are the only participants in the mock proficiency collections, then the monitor must also perform the role of the donor—by interacting meaningfully with the collector trainee to make certain the trainee gets the experience of both uneventful and problem collections. The easiest way to achieve this result is for there to be a third person playing the part of the donor. However, if there are only the monitor and the trainee, but the monitor meaningfully plays the roles of the cooperative and uncooperative donors, the intent of part 40 is fulfilled.
There were comments recommending oral fluid collectors be trained by the manufacturer(s) of the respective oral fluid device(s) the collector intends to use. Some recommended collectors take the manufacturer's online course to get qualified to use each specific device. Others distrusted having specific device training done through the manufacturer's website because they said that would increase costs. One commenter said not to allow manufacturers to train for their own devices because the manufacturer would introduce bias, but a third-party conducting training would not have that bias. One commenter suggested the collector instructor take the manufacturer's device-specific training and use that as the basis for training others. Similarly, a couple of commenters recommended using specific training approved by the manufacturer for its own device. Labcorp strongly encouraged us to require “collectors to complete manufacturers' training on each collection device that will be used for DOT-regulated collections as individual devices have unique features with
respect to proper placement in the mouth, timing, and specimen sufficiency indicators.” One C/TPA said train the trainer courses will be widely available, as they are for urine testing, and oral fluid device manufacturers may take the lead on this. Other commenters discussed the user-friendly nature of the devices (
i.e.,
they usually come with instructions for use or those instructions can easily be read on the manufacturer's website prior to the collection).
We agree with the commenters who were hesitant about specifically requiring the manufacturer's training be used. Considering the user-friendly nature of the devices and that instructors will be teaching oral fluid collectors to use each device the collector is expected to deploy, we amended the proposed language. We have adopted the requirement for a collector to obtain “training to proficiency in the operation of the particular oral fluid collection device(s) you will be using.”
The collector must demonstrate proficiency for each device. We acknowledge several commenters did not want proficiency demonstrations for each device on which a collector is instructed. However, we disagree because the point of the initial proficiency demonstration is to prove the collector was trained on a particular device to full proficiency. If the collector will use more than one device, then the collector needs to prove initial proficiency on each device.
The collector must check the expiration date of the device in each mock collection because using an expired device or failing to enter the “Split Specimen Device Expiration Date” on Step 4 of the CCF would be a fatal flaw under § 40.199. Since the collector will use an oral fluid device that will collect a single specimen, which is then subdivided in the presence of the donor, only one device is to be used. The collector must make the entry on the option marked “Split Specimen Device Expiration Date” instead of the option marked “Primary/Single Specimen Device Expiration Date”. We have been clear that part 40 does not allow the use of a “primary” collection device, meaning one of two collection devices. In addition, part 40 does not allow for a “single specimen” collection device because all devices must be capable of collecting both a primary and split specimen. For DOT-regulated collections, all devices will collect a split and have an expiration date. The collector will enter the expiration date of the single device in Step 4 of the CCF, on the line marked “Split Specimen Device Expiration Date,” which appears directly above Step 5A. The collector would not fill in the “Primary/Single Specimen Device Expiration Date” in addition to the “Split Specimen Device Expiration Date” on the CCF.
We consider proficiency demonstrations to be extremely important. It is one thing to receive instruction on how to use a device, but demonstrating proficiency is literally where the “rubber hits the road.” If a collector cannot demonstrate proficiency on a device, then the instruction received on the use of the device will not remain with the collector in real world collections.
§ 40.33 What training requirements must a collector meet for urine collection?
There were no comments to changing the title of § 40.33 to reflect its focus on urine collectors. We also proposed a change to § 40.33(f) to clarify that damage to a specimen resulting in it being cancelled does not require retraining of the collector, unless the error actually occurred during the collection process. When a specimen is damaged by a delivery truck, sort facility, or other part of the transportation process, or is lost in transit, it is not the result of an error by the collector during the collection process. However, when such damage during the transportation process occurred, some MROs had required collector retraining.
Our proposal to clarify that a collector is not subject to the time and costs of retraining for errors outside the collection process, such as in transportation process events, was met with only supportive comments. In response to the following, we have adopted the change to § 40.33(f).
One commenter, NDASA, said, “Unnecessary error correction has been required for far too many circumstances that are beyond the control of the collector, costing time and cancelled tests.” A combined MRO and C/TPA comment supported the proposal, saying “Previously this was too subtle of a distinction and collectors have been unnecessarily subjected to error correction training when a situation was not their fault. An example is when a bottle leaks in transit where fault is difficult to assign.” In further agreement, Quest Diagnostics said, “Similar to urine collections, problems that occur during shipping that are out of the collector's control should not be held against the collector.” LabCorp also agreed with this proposed change.
Subpart D—Collection Sites, Forms, Equipment and Supplies Used in DOT Urine and Oral Fluid Collections
Some commenters appeared to be confused about testing oral fluid specimens for drugs versus testing saliva for alcohol misuse. Oral fluid drug testing and saliva alcohol testing are completely distinct from each other. The devices, procedures and outcomes are never interchangeable. The provisions applicable to oral fluid testing procedures were proposed as additions in subpart D. The saliva alcohol testing provisions in subparts K through L remain unchanged.
We proposed to reorganize subpart D to accommodate the addition of provisions pertaining to oral fluid drug testing. Sections applying to the DOT drug testing process generally, regardless of specimen type, come first. Renumbered §§ 40.40 and 40.41 contain the content of previous §§ 40.45 and 40.47, concerning the use of the official “Federal Drug Testing Custody and Control Form”, which we continue to refer as the “CCF” in all DOT collections. The 2020 CCF and instructions for completing the CCF for both urine and oral fluid collections are available on the HHS website,
https://www.samhsa.gov.
The DOT has posted the 2020 CCF on our website,
https://www.transportation.gov/odapc.
Some commenters specifically requested ODAPC to provide Specimen Collection Guidelines for both oral fluid and urine, in one combined document. Since not every collector intends to perform both types of collections, we will provide an ODAPC Oral Fluid Specimen Collection Guidelines document, separate from our Urine Specimen Collection Guidelines, after the publication of this final rule.
We proposed changes to the sections of subpart D, including the title of the subpart, which contain the word “urine” or a derivative of that word, if those sections would apply to both urine and oral fluid testing. We added the words “and Oral Fluid” to the title of this section to emphasize subpart D applies both forms of DOT-regulated drug testing collections. We proposed the language “any other appropriate contact information” to permit the inclusion of email addresses or other means of contacting the appropriate parties in the redesignated § 40.44(c)(2). We asked for public comment regarding removing requirements related to fax numbers on the CCF, allowing the fax number if the parties have one, or whether fax numbers were still relevant.
We proposed a provision allowing the Designated Employer Representative's (DER) name and contact information to
be preprinted on the CCF. We asked the laboratories about the availability of space on the CCF to pre-print the information, as well as the logistics and timeliness of sending out updated CCFs with the new DER information. To recognize the responsibility of collectors, as well as collection site operators, for proper collections, we have added “collectors” to the title of § 40.43.
As amended, the newly reorganized §§ 40.42-40.45 covers urine testing (renumbered § 40.42 in the amended rule contains the material previously found in § 40.41, while renumbered §§ 40.44 and 40.45 contain the material previously found in §§ 40.49 and 40.51). To parallel with their urine testing counterparts, new §§ 40.47-40.51 have been added to address oral fluid testing, specifically.
We proposed to modify renumbered § 40.40 to clarify what address and telephone number a collector must provide on the CCF. In January 2002, ODAPC issued a Question and Answer (Q&A) explaining that the collection site address should not be a corporate or “main office” address. In addition, the Q&A stated that the collector's telephone number on the CCF should be the number to directly reach the individual collector and/or the collector's supervisor and not a corporate “toll free” number to a call center. With the modification to § 40.40, if an MRO, laboratory, employer or any DOT staff need to speak with the collector, the telephone number provided on the CCF must give access directly to that collector and/or the collector's supervisor during the collection site's business hours. The collector must not provide a number for a call center. Since this amendment makes the collection site address and collector's telephone number part of the regulatory requirements, we will withdraw the January 2002 Q&A because it is now unnecessary.
If CCFs had already been printed before this final rule was published, the call center number may be on the forms. Service agents (
i.e.,
C/TPAs and collectors) and employers can use these preprinted forms, but they need to cross out the incorrect telephone number and write in the correct telephone number and/or collection site address. There is no need to incur the cost of destroying these CCFs, but we would expect they will no longer be generated with the call center telephone numbers or incorrect addresses after this final rule becomes effective. However, we want to remind collectors and collections sites that they have the responsibility to keep their information current with the laboratories.
We did not receive comments strongly opposing the addition of email addresses, but there were strong proponents for and against using fax numbers. Some commenters said fax machines are outmoded by more secure electronic equipment. LabCorp supported removing the fax number requirement. One commenter said fax machines tend to produce less legible and sometimes illegible copies of the recipient because some labs use lighter ink on their CCFs. One commenter specifically supported replacing the requirement for fax numbers on the CCF with the option and space to include a either a fax number or email address to transmit the CCF to others. In support of using fax numbers, one commenter said faxes are “still a consistent use of transmitting information in a secure manner. Not all organizations are set up with secure transmittal methods and fax still remains more secure than email and is used between clinics, labs and MROs as well as with employers.” A large C/TPA and MRO practice supported the continued use of faxes: “While some collection sites are getting rid of fax numbers, we do not have widely available access to their email addresses. Fax is still commonly used to communicate between collectors, MROs and labs. Confidential communications with collection site should be encrypted yet some of their systems will not allow for this. Faxing still plays a role in our business world and systems are available to keep the information secure in transit.” Another C/TPA commenter wanting us to keep fax numbers echoed, “maximizing the usage of electronic mail and other digital means for document transfer is the most efficient method of communication available today. However, fax communications are still prevalent in the industry, and at this point still an unfortunate necessity.”
In response to the comments, we have decided to keep the option of including a fax number on the CCF, but not require its use. Since many entities no longer use fax machines, it would be an unintended cost to require them to reinstate them. Consequently, in § 40.40(c)(2), we finalized the following proposed language: “Fax numbers may be included, but are not required.”
There were only opposing comments on the idea of including the DER's name and contact information pre-printed on the CCFs. Laboratories, C/TPAs, MROs, and collector trainers said that DERs change too frequently to pre-print a specific name on the CCF, and to fill that information in on the CCF at the time of the collection. One commenter said that, even on an electronic CCF, it can be confusing to need to change the actual DER's name if it is pre-set in the electronic system. Many commenters said pre-printing this would be a waste of money and time because the pre-printed DER names and contact information would need to be crossed out and the correct information written over the cross-outs. This would lead to further confusion.
Consequently, we have not included any requirement for pre-printing the DER's name. It was interesting and informative for us to know that using an electronic system would have difficulties adapting to changing DERs.
We asked for public comment on the use of the term “dry mouth” in § 40.48(c)(1). We explained “dry mouth” is shorthand, similar to the term “shy bladder” used for urine collections, for a situation in which an employee is unable to produce a sufficient specimen. We received no comments on this point, although many commenters had already adopted the term “dry mouth” in their own comments.
One commenter with a nationwide collection network said “multiple oral tests can be conducted simultaneously when in a controlled/supervised environment. All while ensuring the integrity of the individual tests.” That was the only comment opposing the proposal to require the collector to only collect from one employee at a time. We are concerned the distraction of conducting multiple collections at the same time could compromise the security of the collection and potentially impact the fairness and accuracy of the oral fluid test. Consequently, we have adopted this provision to allow the collector to conduct only one collection at a time.
§ 40.49 What materials are used to collect oral fluid?
The Department proposed that all oral fluid collection devices must meet the requirements being set forth in a new appendix B, which is consistent with OTETA's requirement that the specimen must be subdivided from the original specimen in the presence of the employee being tested.
See
49 U.S.C. 45104(5) (aviation industry testing), 49 U.S.C. 20140(c)(5) (rail), 49 U.S.C. 31306(c)(5) (motor carrier), and 49 U.S.C. 5331(d)(5) (transit). Importantly, we noted not all the devices HHS would allow for the OFMG will be allowed for DOT-regulated collections under 49 CFR part 40 because many would not be consistent with OTETA.
Some commenters said DOT and HHS should not allow different devices. One commenter said HHS should only use devices meeting the needs of the DOT program. Another commenter said laboratories charge four dollars per oral fluid collection device, and since every collection would require two devices to create a split specimen, they thought DOT's proposal would save money by mandating a single device, even though it was a sub-dividable device.
Although we discussed the requirements of OTETA in the preamble to the NPRM, one commenter did not realize it was a statutory requirement, saying DOT did not have data to support using a single specimen collection device that gets subdivided. An industry association said it could not find the language in OTETA. One commenter said there was no need to subdivide the specimens, simply use a single collection device, as is done in non-DOT testing. A couple of commenters misunderstood OTETA's requirements and thought that a single specimen subdivided was a concept that DOT created separately from the statute. Several commenters suggested the mouth could be the collection container, thereby allowing separate specimens could be collected from different parts of the mouth to collect a subdivided specimen. Others said the Department did not understand OTETA's requirements and were thereby creating an obstacle that would delay oral fluid testing because the Food and Drug Administration (FDA) could take one to two years to approve new devices. Incidentally, some of these same commenters participated in the public comment period for proposed changes to the HHS OFMG and said it would not be a problem to change the devices and obtain FDA approval in under one year, even on an annual basis, if needed. (
See
87 FR 20522, Apr. 7, 2022). That inconsistency was notable, when compared to the comments some of the same commenters filed to this docket.
When Congress passed OTETA in 1991, it designated DOT as the agency to interpret and carry out the requirements of the statute. The Secretary of Transportation, with certain delegations to the aviation, rail, motor carrier and transit administrations, was charged with continuing its existing drug testing regulations, but enhancements were articulated in OTETA. One of those enhancements was to require “that each specimen sample be subdivided, secured, and labelled in the presence of the tested individual.”
Id.
The Senate Committee Report explained the testing programs were to include “procedures designed to safeguard individual rights and testing procedures which shall . . . Provide that each specimen sample be subdivided, secured, and labeled in the presence of the tested individual . . .” Senate Report: Omnibus Transportation Employee Testing Act of 1991, S. Rpt. 102-54, pp. 20-21 (May 2, 1991). In addition, the Senate Report explained, “These safeguards are critical to the success of any testing program. They are designed to ensure that an individual's basic rights to privacy are protected and that there is accountability and accuracy of testing.”
Id.
Having a single specimen collected and subdivided in the presence of the tested individual is the core issue in the decisions we have made regarding what device features would be acceptable in the DOT oral fluid testing program. Congress clearly articulated collecting a single specimen that is subdivided in the presence of the tested individual is a critical safeguard for the individual and it provides assurance of the accountability and accuracy of the testing program. Furthermore, the safeguard of a single specimen subdivided in the presence of the individual being tested is a right OTETA ensured for individuals being tested. As we said in our 2000 preamble to the plain language rewrite of part 40, “When Congress guarantees a right to employees (and we believe we must treat all DOT-regulated employees in our program alike, even if they are not covered by the Omnibus Act), our obligation as a Federal agency is to faithfully execute that legislative decision.” (65 FR 79467 Dec. 19, 2000).
Requiring a device that permits a single specimen to be collected and subdivided in the presence of the donor is both a statutory requirement and a reasonable expectation. The Department is acting within its authority to carry out such reasonable and clear requirements in legislation entrusted to it.
Assuming in the alternative that the statute is not considered to be clear on its face, the DOT is the Federal agency charged by Congress to interpret OTETA and we are utilizing our ability to interpret the statutory authority vested in us. The precedent for this ability to interpret statutes has been supported for almost forty years in the cases following
Chevron
v.
Natural Resources Defense Council,
467 U.S. 837 (1984). In
Chevron,
the leading case on the authority of agencies to interpret statutes through rulemaking, the Supreme Court articulated the following standard:
When a court reviews an agency's construction of the statute it administers, it is confronted with two questions. First, always, is the question of whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction of the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute. (Id. at 842-43).
In applying the Chevron analysis, courts will strike down an agency regulation or interpretation when there is something in the statute specifically precluding the action the agency had taken. Actually, OTETA confirms the Department's broad authority to carry out its drug and alcohol testing responsibilities. When the intent of Congress is clear, as is the case here, no further inquiry is necessary.
Thus, the Department is acting within its statutory authority to carry out such reasonable requirements in legislation entrusted to it. The statute unambiguously provides that samples for drug testing must be subdivided, or “split.” To the extent that that the statute requires interpretation, the DOT's implementation of the statute is reasonable and is, therefore, entitled to deference.
See Chevron
v.
Natural Resources Defense Council,
467 U.S. 837 (1984).
Consequently, as we proposed, all devices meeting the requirements in Appendix B will allow a single specimen to be subdivided in the presence of the donor. For example, a device could allow two specimens to be collected simultaneously using a single collection device, which directs the oral fluid into two separate collection tubes; or a specimen could be collected with a single device, which is inserted into the mouth and can be subdivided into two separate collection tubes. We would also allow a device to have two pads joined together for the collection in the same part of the mouth, as long as they can be separated in the presence of the employee being tested. We do not agree with the creative suggestion of allowing the mouth to be the collection container.
We have made slight modifications to the proposed rule language in Appendix B to encompass this broader intention of what is acceptable under OTETA. We think it is reasonable to allow a device with either one or two pads that can be subdivided and sealed in the presence
of the employee to be consistent with OTETA.
One commenter who is a collector pointed out that there is already at least one patented device that would meet the requirements of OTETA. This commenter said she has experience using that device and it is far superior to others on the market. She noted problems with other oral fluid collection devices “such as: inadequate specimen for multiple drug confirmations; sample-adequacy indicators are not reliable indicators of specimen volume as donors attempting to `beat' the test often suck on the device to draw saliva out of the paddle or swab; absorbent material in paddles/swabs have no consistency in sample volume collected; there is no standardization of oral fluid collection devices that a offers a reproducible, sufficient (1 mL) sample . . .” As manufacturers develop new devices capable of being subdivided in the presence of the donor, we expect that any such problematic issues with oral fluid collection devices will be resolved.
We have included below, in the Section-by-Section analysis of Appendix B, more comments regarding the specifics of what we proposed for collection device kits. A full discussion of the specific comments can be found there.
§ 40.61 What are the preliminary steps in the drug testing collection process?
We proposed changes to § 40.61(a) to remind C/TPAs for motor carrier owner/operators of the C/TPA's respective nondelegable duty to make a determination of whether a refusal has occurred when an employee fails to timely report for a test that is not for pre-employment. We received only supportive comments. We have adopted the changes and have added similar language to this section to remind employers of their duty to make a determination on refusals. We have added language in the final rule to reiterate the responsibility for the employer or C/TPA of the owner/operator to make the actual refusal determination required under §§ 40.191(a)(1) and 40.355(i) and (j).
There were no comments regarding modifying § 40.61(b)(1) and (3), to use the term “drug testing” or “drug test” in place of “urine,” since the provision applies to the testing of either specimen type. We have adopted these changes as proposed.
We proposed to split the existing § 40.61(b)(3) into (b)(3) and a revised (b)(4), and there were no comments. We have revised § 40.61(b)(3) to prohibit collection of any kind of specimen from an unconscious donor. The revision to § 40.61(b)(4) includes the remaining sentences of the current § 40.61(b)(3), with a change to the final sentence of proposed subparagraph § 40.61(b)(4). The final sentence in § 40.61(b)(4) emphasizes the actual employer must decide whether a given circumstance constitutes a refusal, as is required by § 40.355(i). When a directly observed test is needed, either a directly observed urine collection or oral fluid collection will suffice, and the collector will note on the CCF whether a directly observed urine or oral fluid test was conducted under § 40.61(f)(5)(i).
There was a comment to § 40.61(f)(5)(i). The commenter said the “collector should have clear instructions on when the type of sample can be switched. Ideally the collector would get instruction from the DER, however the DER is rarely available when a problem collection arises.” We agree that this instruction should come from the DER. That instruction should be provided in advance of the tests when possible. These are the kinds of details employers and collection sites should be discussing in their regular course of business. We disagree that it should be a regulatory requirement.
DOT-regulated entities are required to use HHS's OMB-approved CCF. DOT worked closely with HHS on the current CCF, which incorporated changes necessary as a result of HHS's establishment of scientific and technical guidelines for the inclusion of oral fluid specimens in the Mandatory Guidelines for Federal Workplace Drug Testing Programs. The majority of changes to the CCF were made to allow the collection of oral fluid specimens, which have not been authorized in the DOT drug testing until this final rule and will not be fully implemented until HHS certifies at least two laboratories.
In response to the HHS revisions to the CCF, we proposed changes to §§ 40.61(e) and 40.79(a)(1) (formerly § 40.73(a)(1)). The instructions for completing the old CCF were provided on the back of Copy 5 of that form. These instructions are not provided on the revised CCF. Instead, instructions for completing the form can be found on the HHS and DOT (ODAPC) websites. We proposed amending § 40.61(e) to instruct the collector to tell the employee they can find instructions for completing the CCF on specific HHS and DOT websites. We received the following comments to these changes.
Airlines for America (A4A) supported the amendment to require the collector to “notify the employee that instructions for . . . the CCF can be found at the HHS . . . and DOT . . . websites.” Quest Diagnostics suggested, “a printed and legible copy of the instructions for completing the CCF should be available to both the donor and collector to follow as part of the collection process during all collections. Provision of a printed copy should be a collector's responsibility in the event electronic access is not available.” While we agree with the spirit of this latter comment and would encourage collectors to have a legible copy of the CCF instructions available, we envision it as a good business practice and not a regulatory provision. To require paper copies of this to be provided to each donor seems to be an unnecessary paperwork burden to employers and their collection personnel. Having a laminated copy available at the collection site is also a good idea. As long as these directions are available electronically through the DOT and HHS websites, they will be available to all employees. We have finalized § 40.61(e) as proposed.
We received a comment from a labor organization asking for a new requirement to be added to § 40.61(b). Specifically, they asked us “to add a requirement that for union represented employees to be informed by the collector that the employee being tested has the right to have a union representative present during the process.” It is unlikely that collectors would know this information. We consider this comment outside the scope of this rulemaking, but it can be addressed in individual collective bargaining agreements between unions and their employers.
Also, we proposed amending redesignated § 40.79(a)(1) to note the employee must provide all information required in Step 5 of the revised CCF. This information includes the donor's printed name and signature, date of the collection, date of birth, daytime and evening phone numbers, and email address (if the donor has one they are willing to share).
One commenter asked that we not require the collector to make a remark on the CCF if the donor's email address, date of birth, or telephone numbers are not in Step 5 of the CCF. This commenter said requiring this notation as a remark on the CCF “could have a catastrophic impact on the collection process, expose employers to privacy complaints, create unnecessary test cancelations, increase administrative costs, and add another point of potential conflict between the donor and collector.” The commenter thought the requirement to provide two phone numbers and an email address would be a violation of the employee's privacy
rights. However, the commenter did not have an issue with providing the donor's name, SSN and date of birth.
We disagree that additional information on the CCF is a violation of the employee's privacy. If the information required in Step 5 of the CCF is not properly completed by the employee, the collector has a duty to attempt to get the employee to provide the information or note in the remarks section that this was not done. As with all problems at the collection site, it is best to document them as soon as possible.
One commenter, NDASA, asked about situations in which the employee does not have a second phone number. This commenter asked that we allow the collector to write “Not applicable” or some derivation of that phrase on the CCF, to note the absence of the second number was not available and not simply an oversight. That is a reasonable suggestion and common-sense approach. We have not included this in the regulatory text. Instead, we will include it in our collection guidance. We have finalized § 40.79(a)(1) as proposed.
§ 40.63 What steps does the collector take in the collection process before the employee provides a urine specimen?
We proposed to modify § 40.63(a) to remind collectors to ensure that all items in Step 1 of the CCF are completed. Specifically, we proposed to add a parenthetical to remind collectors to check the box for the DOT agency in Step 1.D, and to write an address for the actual collection site in Step 1.G.
Quest Diagnostics commented in support of “the reminder to collectors to check the box for the DOT agency in Step 1.D, and to write an address for the actual collection site in Step 1.G.” Similarly, industry trade associations supported the change. There were no opposing comments. We have adopted the changes as proposed.
§ 40.65 What does the collector check for when the employee presents a urine specimen?
We proposed to modify § 40.65 to ensure that when an immediate re-collection under direct observation is needed (
e.g.,
because the temperature of a urine specimen is out of range or there are signs of tampering), regardless of whether the first specimen was urine or oral fluid, the required directly observed collection could be either urine or oral fluid. For example, if a directly observed collection is needed after a urine collection, the second could be either an oral fluid collection (inherently directly observed) or a urine collection carried out under the direct observation procedures set forth in § 40.67. After the second collection is done, each specimen collected must be sent to the appropriate laboratory (
i.e.,
a laboratory certified by HHS for that specimen type). We asked for public comment about who should make the decision as to the methodology for the second collection.
ARCpoint Labs, a nationwide network of collection sites, commented that the collector should be the one “to determine the type of second collection that is performed. This will allow maximum flexibility based on environment, oral/urine kits available for that client, and the collectors experience.” This commenter also pointed out that moving from a urine collection to an oral fluid for the purpose of obtaining a directly observed collection would remove the need to conduct a more invasive urine direct observation.
Conversely, Labcorp, which is an HHS-certified laboratory and owner of a large network of collection sites, opposed “allowing the collector to independently determine when an alternate specimen should be collected or requiring that the collector contact the employer each time an alternate specimen type is collected.” Labcorp also said the identification of what specimen type is used and when it should be used should not be in the regulation and should be in the agreement between the employer and the collection site. A C/TPA requested that a “collector should have clear instructions on when the type of sample can be switched.” Similarly, the New York City Department of Transportation recommended advance communication between the DER and the service agent “to ensure that an alternate methodology is authorized with devices and laboratories as designated. In the event an alternate methodology is needed, the collector should contact the employer (DER) and/or service agent (TPA/MRO) immediately. They will make the decision on which device to use.”
We agree there should be clear communication between the employer and their service agent(s) who conduct the collection to ensure there is a process set up in advance. That process would determine whether the collection would either continue with the same methodology as the collection began or switch to the alternate methodology to complete the second test (
e.g.,
under direct observation or to complete the test when there is a shy bladder scenario). As Labcorp noted, moving to oral fluid for a directly observed collection is less invasive than moving to a urine collection under direct observation.
When there is a need to determine whether an alternate specimen should be used, it is advisable for an employer to have a standing order in place to deal with such situations. The different specimen type could be chosen by the employer (through a standing order or a discussion with the collector) or its service agent (
i.e.,
if there is no standing order and the collector cannot contact the DER) to complete the collection process for the testing event.
As several commenters supported, this should all be discussed and arranged in advance. We do not believe this is something the Department should regulate. The employer and its service agents are in the best position to assess the costs and logistics of the collection, set up the appropriate contracts with collectors and laboratories, and determine the most effective way to conduct a second collection under direct observation. The proposed language sets up the performance standard for the second collection to be accomplished without interfering in these contractual relationships between employers and their service agents. Consequently, we have finalized the proposed language without further changes.
§ 40.67 When and how is a directly observed urine collection conducted?
We proposed to modify the title of the section to add the word “urine”. This clarifies its applicability solely to how and when directly observed urine collections will occur. We received no comments on this point and have adopted the change to the title.
One commenter asked why we did not include permission for an employer to send an employee in for an immediate recollection if the employer discovered a direct observation should have been conducted but was not. The commenter pointed out the employer could do this only when the service agent noted this for the employer. We agree with this commenter and, as a logical outgrowth, we have added a § 40.67(a)(4) to permit this and to tie in the action expected of the employer when a service agent notifies the employer under § 40.67(n) that a required direct observation was not done.
We proposed minor changes to § 40.67(c) and (d). We received a public comment requesting an additional modification to the proposed § 40.67(d). That commenter asked for a language change to have the collector inform the employee a direct observation is
necessary because the specimen did not meet Federal guidelines. We will not make that change because we believe it will cause confusion between the HHS guidelines and DOT's regulation, part 40. We have finalized the changes to § 40.67(c) and (d).
In the most substantive proposed change to § 40.67, we offered an amendment to § 40.67(g) to address situations where a same gender observer is not available for the collection of urine specimens. We requested and received public comment on whether a licensed or certified medical professional legally authorized to take part in a medical examination in the jurisdiction where the collection takes place should be permitted to be opposite gender observers. We explained that we were proposing this option to reduce the circumstances in which an observed urine collection might be delayed for lack of a same-gender observer.
We received a significant number of comments on proposed § 40.67(g). Some commenters thought that it would be a good idea to allow certain specified medical professionals to be direct observers regardless of gender because a same-gender observer is not always present in a collection site, and others mentioned how transgender and nonbinary gender individuals pose a challenge for finding a same-gender observer.
The majority of commenters on this subject opposed the proposal. The opposing comments included concerns about sexual advances, stress to donors, and accusations of assault that would lead to liability for medical professional serving as the observer. Some commenters asked that we leave the same gender direct observation provision exactly as it is in § 40.67.
While we acknowledge the concerns of the commenters who opposed the proposal, we agree with the commenters who wanted to see some changes made to accommodate situations where a same-gender observer cannot be easily provided and in the less common situations of transgender and nonbinary gender individuals who will be subject to a direct observation collection. Oral fluid testing offers a completely appropriate solution for all of these scenarios because every oral fluid collection is a directly observed collection without the need for a same gender individual to perform that observation.
Consequently, we have not added the proposed provision to allow a different gender direct observer who is a medical professional. If a directly observed urine collection is required, the burden remains on the employer to provide the same-gender observer if the collection site cannot do so, or to permit an oral fluid test. The responsibility of ensuring the collection takes place has always been the employer's requirement. If the employer has a standing order that all directly observed collections will be conducted as oral fluid, then there is no need for the collector to call the DER. Otherwise, the collector will use the telephone number listed on the CCF where the DER can be reached at any time of the day or night the testing is being conducted. If a collector cannot find a same-gender observer, the collector needs to let the DER know that one must be immediately provided for the collection, unless an oral fluid standing order exists.
In the case where the employee identifies as transgender or nonbinary gender, the burden remains on the actual employer to ensure the direct observed collection will take place. We have added § 40.67(g)(3) to require that when a same gender collector cannot be found, unless the employer has a standing order to allow oral fluid testing in such situations, the collector must contact the DER and either conduct an oral fluid test because the collection site is able to do so or send the employee to a collection site acceptable to the employer for the oral fluid test. Even if an employer does not usually utilize oral fluid testing, that employer should have agreements or arrangements either directly, or through its C/TPA, for oral fluid testing to be used for directly observed collections of transgender or nonbinary employees. In the alternative, the employer could establish in-house collections for such situations. We encourage employers to arrange for oral fluid testing in advance, in order to plan for such contingencies.
We want to clarify that the collector does not enter the reason for the direct observation in the “Remarks” section of the CCF if the employer is sending the employee in for a required directly observed collection (
e.g.,
a return-to-duty test, a follow-up test, a test where the MRO has instructed the employer to send an employee in for a directly observed collection). The “Remarks” section would be used only when the collector moves to a directly observed collection and the employer did not know about it in advance (
e.g.,
temperature out-of-range, or signs of tampering). Thus, we have amended § 40.67(e)(2) to change a cross-reference to § 40.67(b) to become a cross-reference to § 40.67(c)(2) through (4). This is because § 40.67(e)(2) is an instruction to collectors to follow through with an entry on the “Remarks” line on a CCF when an event under § 40.67(c) takes place. This has nothing to do with § 40.67(b), so this cross-reference has been corrected. We also proposed to make a technical amendment to § 40.67(c)(1) to strike the reference to paragraph (b) because it is an incorrect reference. There were no comments opposing any of these edits to § 40.67, so we have adopted them, as proposed.
§ 40.69 How is a monitored urine collection conducted?
There were no comments on the proposed new introductory language in § 40.69(a) to emphasize a monitored collection will be conducted if the collector is using a multi-stall restroom and the collector cannot secure all sources of water and other substances that could be used for adulteration and substitution (§ 40.42(f)(2)(ii)). Also, there were no comments about the proposed edits to § 40.69(e) to update cross-references in part 40 that were renumbered. We have adopted these changes as proposed.
§ 40.71 How does the collector prepare the urine specimens?
The final rule makes a minor clarifying change, instructing the collector of a urine specimen to check both the boxes for “urine” and “split specimen” on the CCF. We received one comment, which requested we add the words “after the collection” for the purpose of reminding the collector to check the boxes under Step 2 after the collection takes place. We agree this would be helpful. We have adopted the change to § 40.71(b)(1), with this modification.
§§ 40.72-40.74—Collection Procedures for Oral Fluid Testing
These three new sections establish the collection procedures for oral fluid testing. They are consistent with the HHS OFMG (84 FR 57554, Oct. 25, 2019).
There were many substantive points discussed in the comments that were extremely helpful to the Department. Commenters in the medical field, collectors experienced in non-DOT collections, laboratories, associations, and others discussed practical tips, potential problems and other factors for us to consider. In response to those comments, we made the following changes explained below.
The American College of Occupational Medicine (ACOEM) questioned whether oral fluid collectors would be well-enough trained to determine whether a donor is “cheeking”, which they said is “a practice of hiding medication or
contraband in the mouth between the cheek and gums.” This association, with a membership of very knowledgeable health care professionals, warned of “substitute saliva (complete with the proper amount of albumin or immunoglobulin biomarker) which is far easier to conceal and maintain at body temp than 30 cc of urine” and the rise of other products to cheat oral fluid testing. They also asked whether collectors would “be trained to carefully examine the entire mouth,
i.e.,
using a dental mirror, to assure that the donor has not concealed an adulterant or substitute saliva sample in their mouth?” ACOEM also encouraged us to include such instructions in our Oral Fluid Collection Guidelines to “make sure that the proper initial inspection process of the oral cavity is included.”
To ensure proper training can be done, we must first ensure the regulatory text is clear and provides the necessary details. Consequently, we chose to address the substantive concerns about substituting and adulterating tests here, in § 40.72(a), instead of the collector training provisions of the regulation.
We agree with ACOEM about the potential for adulterating, substituting, or otherwise interfering with an oral fluid test exists, even though all oral fluid tests will be directly observed. The final rule requires the employee to open their mouth and allow the collector to fully inspect the oral cavity. The collector is required to check the oral cavity to ensure that it is free of any items that could impede or interfere with the collection of an oral fluid specimen. In § 40.72(a), we have provided the examples of “candy, gum, food, or tobacco”, which is not an exclusive list because there could be more items that are inadvertently present in a donor's mouth. However, we also included in § 40.72(a) that the collector needs to be checking for anything that could be used to adulterate, substitute, or alter the specimen. As this commenter suggested, we will provide further guidance on inspecting the oral cavity within our oral fluid collection guidelines to remind collectors to conduct oral fluid testing in well-lit areas and recommend, as a best business practice, the collector have a flashlight available for oral cavity inspection.
In response to the concerns of ACOEM and other commenters, we have amended the proposed § 40.72(a)(1) and created a new § 40.72(a)(2). Specifically, we have added “If the collector finds indication(s) of anything identified above, the collector will ask the employee to lift their tongue and/or separate their cheek from their gum to permit full inspection.” Although we do not believe every oral cavity inspection will require the employee to lift their tongue and/or separate their check from their gum, we want to provide this as an option for the collector to utilize within their discretion. We also added a sentence to allow the employee to cleanse their hands if they need to touch their own mouth to allow further inspection by the collector.
On the specific subject of tobacco, one commenter asked how oral fluid testing “interacts chemically with employees who will use tobacco products via dip, smoke or chew prior to testing and of course various mouth washes to cover up.” The HHS looked at this specific subject when formulating its OFMG. See 84 FR 57565 (Oct.25, 2019). The dark brown juice resulting from some forms of tobacco use can cause discoloration that may interfere with initial testing. This is part of the reason why there is a wait period prior to collection, so the employee can clear their mouth of any material that might stain the collected oral fluid.
In § 40.72(a)(3), the Department c
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