{"operation":"document","citation":"73 FR 35961","title":"Procedures for Transportation Workplace Drug and Alcohol Testing Programs","source_type":"rulemaking","agency":"Office of the Secretary","status":"historical","official":true,"published_on":"2008-06-25","effective_on":"2008-08-25","summary":"The Department of Transportation is amending certain provisions of its drug and alcohol testing procedures to change instructions to collectors, laboratories, medical review officers, and employers regarding adulterated, substituted, diluted, and invalid urine specimen results. These changes are intended to create consistency with specimen validity requirements established by the U.S. Department of Health and Human Services and to clarify and integrate some measures taken in two of our own Interim Final Rules. This Final Rule makes specimen validity testing mandatory within the regulated transportation industries.","machine_formats":{"json":"https://regulus.evalyn.ai/document/federal-register-e8-14218.json","markdown":"https://regulus.evalyn.ai/document/federal-register-e8-14218.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-e8-14218","source_url":"https://www.federalregister.gov/documents/2008/06/25/E8-14218/procedures-for-transportation-workplace-drug-and-alcohol-testing-programs","body":"Federal Register, Volume 73 Issue 123 (Wednesday, June 25, 2008) [Federal Register Volume 73, Number 123 (Wednesday, June 25, 2008)] [Rules and Regulations] [Pages 35961-35975] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: E8-14218] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 40 [Docket No. OST-2003-15245] RIN 2105-AD55 Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office of the Secretary, DOT. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: The Department of Transportation is amending certain provisions of its drug and alcohol testing procedures to change instructions to collectors, laboratories, medical review officers, and employers regarding adulterated, substituted, diluted, and invalid urine specimen results. These changes are intended to create consistency with specimen validity requirements established by the U.S. Department of Health and Human Services and to clarify and integrate some measures taken in two of our own Interim Final Rules. This Final Rule makes specimen validity testing mandatory within the regulated transportation industries. DATES: This rule is effective August 25, 2008. FOR FURTHER INFORMATION CONTACT: Jim L. Swart, Acting Director (S-1), U.S. Department of Transportation, Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey Avenue, SE., Washington, DC 20590; telephone number (202) 366-3784 (voice), (202) 366-3897 (fax), or [email protected] (e-mail). SUPPLEMENTARY INFORMATION: Background The Omnibus Transportation Employee Testing Act of 1991, 49 U.S.C. 31300, et seq., 49 U.S.C. 20100, et seq., 49 U.S.C. 5330, et seq., and 49 U.S.C. 45100, et seq. (the Omnibus Act), requires the U.S. Department of Transportation (DOT) to use the laboratories certified by, and testing procedures of, the U.S. Department of Health and Human Services (HHS) to ensure ``the complete reliability and accuracy of controlled substances tests.'' Since Congress specifically limited the scientific testing methodology upon which the DOT can rely in making its drug and alcohol testing regulations, we follow the HHS scientific and technical guidelines, including the amendments to their Mandatory Guidelines. In its final rule of December 2000 [65 FR 79526], the U.S. Department of Transportation (DOT) made specimen validity testing (SVT) mandatory for the transportation industry contingent upon the HHS publishing its Mandatory Guidelines on SVT. DOT anticipated that HHS would, sometime in 2001, amend its Mandatory Guidelines to establish SVT requirements for HHS-certified laboratories. When it appeared that HHS would not establish final SVT requirements in 2001, we amended 49 CFR part 40 (part 40) to remove the mandatory requirement. We believed it advisable to wait until HHS completed its amendment before making SVT mandatory throughout the transportation industries for all DOT specimens. On August 9, 2001, the DOT amended part 40 [66 FR 41952] to remove the mandatory requirement because HHS had not finalized its Mandatory Guidelines regarding SVT. SVT would remain authorized but not required. The DOT issued a May 28, 2003 interim final rule (2003 IFR) [68 FR 31626] in response to scientific and medical information suggesting we modify testing criteria for some specimens that had been considered to be substituted and ultimately were treated as refusals to test. The 2003 IFR modified how the medical review officer (MRO) would deal with any substituted result with creatinine concentrations equal to or greater than 2, but less than or equal to 5 mg/dL [hereafter, ``2-5 mg/ dL range'']. It did not change the HHS substitution criteria that we had used. On April 13, 2004, the HHS published a Federal Register notice revising its Mandatory Guidelines [69 FR 19644] with an effective date of November 1, 2004. Among the revisions contained in the HHS Mandatory Guidelines were requirements that laboratories modify substituted and diluted specimen testing procedures and reporting criteria. The HHS also revised [[Page 35962]] laboratory requirements for adulterated specimen testing and made SVT mandatory for Federal employee testing under the HHS Federal Workplace Drug Testing Program. In an IFR (2004 IFR) [69 FR 64865] published on November 9, 2004, the DOT changed a number of items in part 40 to make them consistent with the HHS Mandatory Guidelines. We did this to avoid conflicting requirements that implementation of both rules would have had on laboratories and MROs. While the HHS Mandatory Guidelines' approach to substituted test results allowed DOT to simplify its guidance to MROs on how to deal with those results, there were several important differences between the 2004 IFR and the HHS Guidelines. The most important among them was the fact that SVT, though authorized by part 40 and the 2004 IFR, was not yet required. In the 2004 IFR, we indicated that we intended to fully address all aspects of the HHS changes to their Mandatory Guidelines in a notice of proposed rulemaking (NPRM). We also said that we would take into consideration any subsequent HHS materials (e.g., HHS MRO Manual) and would update our cost figures for SVT in the context of making SVT mandatory. Subsequently, the DOT published--on October 31, 2005--an NPRM [70 FR 62276] responding to comments made to the 2003 IFR and to the 2004 IFR. The NPRM also proposed making SVT mandatory and included a number of other proposed technical changes, mostly clarifying the procedures related to testing and reporting of adulterated, substituted, and invalid specimens. Summary of NPRM Comments A total of 27 commenters responded to the 2005 NPRM, making 234 separate comments. Eight commenters were individuals with no known affiliations; seven were MROs representing themselves or their organizations; two were employers; one was a Third-Party Administrator (TPA); four represented associations; four represented labor unions; and one represented a drug testing laboratory. Eleven commenters expressed general support for the DOT effort to establish clear requirements for SVT that were consistent with the HHS procedures. Of these eleven, one individual thought the SVT rules should be more rigorous; four others commended the DOT in its efforts; one TPA thought the effort admirable; two labor unions commended and supported the DOT's efforts; one association applauded the effort; and one laboratory supported DOT efforts to bring more consistency on SVT with the HHS. Six commenters specifically supported making SVT mandatory and five specifically opposed this proposal. Several stated that authorizing SVT is sufficient to address adulteration and substitution issues. A number of commenters provided numerous technical suggestions, supported most of the proposed changes or additions, and were interested in establishing relevant procedures to address the various issues of adulterated, substituted, and invalid test results. A number of commenters were concerned about the current state of science related to SVT testing as compared to that of drug testing. At least two commenters believed the DOT needed to require laboratories to utilize two separate methodologies for certain SVT. However, this would require laboratories to change testing protocols that the HHS does not mandate. A number of commenters supported the DOT's proposal to rectify past problems related to substituted specimens and suggested a number of options and recommendations. We appreciate the input from the commenters and considered their comments in the Informational Notice Regarding Certain Substituted Specimens published in the Federal Register on September 11, 2007 [72 51887]. Because we addressed those issues in that notice, we will not deal with them in this final rule. A number of commenters raised part 40 issues unrelated to the proposed SVT issues. We have not addressed these unrelated items in this preamble because they are outside the scope of the NPRM. Finally, the NPRM proposed or asked a number of major policy questions relevant to SVT. We specifically address major policy issues in a separate section and address the others in section-by-section discussions. Principal Policy Issues Mandatory Specimen Validity Testing The DOT proposed making SVT mandatory, as in the current HHS Federal employee testing program. Most commenters concurred with DOT's proposal to make SVT mandatory. Some commenters acknowledged this was necessary because the increase in products designed to adulterate specimens has made tampering with specimens more prevalent. The commenters also supported mandatory SVT because it would bring better control over the SVT process. A number of commenters expressed concern that the science of SVT has yet to evolve to the same level of accuracy, reliability, and defensibility as the science of drug testing. Some of these commenters recommended that SVT should remain elective. Several commenters believed that the DOT should require all laboratories to employ two separate SVT methodologies for adulterants because this would ensure more confirmed adulteration results. The commenters reasoned that laboratories would be more likely to report invalid results if they only used one SVT methodology. Other comments on mandatory SVT included concerns about costs and the extent of adulterant testing. Some commenters believed the DOT's cost estimates for SVT were low. They requested clarification on the anticipated costs of initiating mandatory testing. Commenters also expressed concerns that laboratories were not testing for all adulterants. DOT Response The DOT continues to believe that mandatory testing for specimen validity is an appropriate response to the use of adulterants and attempts to subvert the collection and testing process. The HHS Mandatory Guidelines established SVT requirements with which laboratories must comply in order to become and remain HHS-certified. The HHS has stated that its SVT standards are designed to produce the most accurate, reliable, and correctly interpreted test results. Currently, when DOT specimens are tested for validity, the HHS procedural standards apply. There is no reason to presume that these standards are scientifically insufficient. Therefore, we will require that urine specimens tested under the DOT-industry programs will be subject to the HHS procedural standards for SVT. We will continue to utilize HHS instructions to laboratories for establishing cutoffs and directing laboratory analysis regarding creatinine levels. Within part 40, we added procedures to allow an employee to provide evidence to the MRO that he or she can produce a urine specimen below the 2.0 mg/dL cutoff. We created this procedural safeguard in the 2000 regulation because a small number of employees assert they may be capable of providing urine specimens with creatinine levels below 2.0 mg/dL, and that such low creatinine levels are not the result of tampering with their specimens. By adding an evidentiary process for results below the 2.0 mg/dL cutoff, we believe that we have created [[Page 35963]] sufficient safeguards to protect employees from being wrongfully accused of tampering with their specimens. The DOT shares the commenters' concerns about laboratories choosing to use one adulterant testing methodology because using one methodology instead of two may result in obtaining invalid results rather than confirmed adulterated results. However, HHS mandates all scientific and procedural requirements for drug testing at HHS-certified laboratories. HHS provides guidance to the laboratories on use of a secondary confirmatory methodology when a laboratory performs confirmatory adulteration testing. HHS authorizes, but does not require, laboratories to perform confirmatory adulteration testing. The Omnibus Act requires the DOT to incorporate the HHS scientific and technical guidelines, and we do not have the authority to impose additional scientific and technical requirements upon the laboratories. While current laboratory testing data show a slight rise in invalid results and a slight decline in adulterated results over previous years, we do not have data based solely upon implementation of full SVT because the DOT has not required full implementation. As a consequence, the DOT will initiate permanent 6-month reviews of laboratory data on DOT-regulated specimens to obtain more specific information about this issue now that SVT will be mandatory for all DOT-regulated specimens. We will look at the reasons drug test results are classified as invalid versus adulterated to determine if use of one methodology instead of two is likely to cause more invalid results and fewer confirmed adulterated results. Part 40 requires laboratories to submit to DOT specific information regarding their SVT following full implementation. The regulatory text requiring this information is at Sec. 40.111; and the required data are listed at Appendix C. We will use this information in our continuing discussions with HHS and others regarding SVT. We also want the information so that we can know the full scope of laboratory data on DOT-regulated tests. The DOT cost estimates for full SVT and for laboratory data collections are in the regulatory analyses and notices section of this preamble. Requirement for Laboratories To Contact MROs Before Reporting Invalid Results The DOT asked if we should continue to require laboratories to contact MROs before reporting invalid results. Several commenters, mostly MROs, responded to this question and generally indicated that laboratories are not routinely contacting them about invalid results as required by HHS and DOT. Some commenters were concerned that the rule text does not specify whether the MRO or the laboratory has the final decision on the disposition of the specimen. Also, the commenters expressed concern about whether the employer would be required to pay for sending the specimen to another laboratory. One commenter pointed out that DOT is requiring the MRO to discuss the result with ``the certifying scientist'' while HHS requires the MRO to discuss the result with the ``laboratory.'' Some laboratory personnel other than a certifying scientist, for example the Responsible Person (RP), may discuss invalids with the MRO. This commenter supported having the MRO talk with ``a certifying scientist.'' DOT Response The rule continues to require laboratories to contact the MRO prior to reporting an invalid result, a requirement which mirrors the current HHS Mandatory Guidelines. The fact that some laboratories may not be following this requirement is not sufficient reason to suspend or disregard this procedure. The HHS identifies 12 separate criteria for identifying a specimen as invalid. Of these 12, the first three do not require laboratory contact with MROs. It is entirely possible that many of the invalid results fall under these three criteria and may explain the reason that contact between the laboratories and the MROs appears lacking. These three criteria are: 1. Inconsistent creatinine concentration and specific gravity results; 2. The pH is greater than or equal to 3 and less than 4.5, or greater than or equal to 9 and less than 11; or 3. The nitrite concentration is greater than or equal to 200 mcg/ mL, but less than 500 mcg/mL. As indicated before, some laboratory testing methodologies may differ. If the invalid result is related to the criteria listed in the HHS Mandatory Guidelines--under sections 2.4(7), (iv) through (xii), the MRO and laboratory might conclude it is beneficial to conduct another test at a different laboratory to obtain a result that is not invalid. This would require a certifying scientist and the MRO to discuss the benefit of sending the specimen to another laboratory and to determine which laboratory would be able to conduct the appropriate test. A few commenters requested that DOT specify whether the MRO or a certifying scientist would make the determination to send a specimen to another laboratory. The DOT believes this is a mutual decision to be made by both the MRO and a certifying scientist. Regarding payment for additional testing, the DOT's position is similar to our stance on paying for split specimen testing. Regardless of who pays or how, it is the employer's responsibility to ensure that procedures are in place to accomplish the additional testing. We believe the cost of any additional tests would be less than the subsequent cost of recollecting under direct observation when the first laboratory reported the result as invalid. One commenter said that the NPRM's reference to the MRO's conferring with ``the certifying scientist'' should remain ``a certifying scientist''--as it is in the current rule text. We agree, and our regulation reflects this. HHS Blind Specimen Certification Criteria The DOT proposed to adopt the HHS blind specimen certification criteria. HHS provides technical oversight to the laboratories, and quality control is part of that very important oversight. We did not receive comments regarding this proposal. Therefore, the DOT has adopted the HHS criteria for blind specimen certification. Recollection Under Direct Observation When Creatinine Is in the 2-5 mg/ dL Range The DOT proposed adopting the 2004 IFR's approach to the treatment of negative-dilute specimens with creatinine in the 2-5 mg/dL range, which requires recollection under direct observation. The DOT requested comments about continuing this requirement. The majority of commenters supported the proposal to require recollections under direct observation for negative-dilute results with creatinine in the 2-5 mg/ dL range. Several commenters indicated that there was an increase in positive results from the directly observed recollections, while others stated the results were mostly negative. Most of these commenters provided anecdotal information. However, one commenter's data showed that a significant number [[Page 35964]] of the directly observed recollections produced non-negative results. DOT Response The DOT will continue to require the MRO to direct employers to conduct immediate recollections under direct observation when the original specimen is reported with a creatinine concentration in the 2- 5 mg/dL range. We think the number of non-negatives produced during directly observed recollections is significant and justifies continuing the recollection requirement. Although a few individuals claim the ability to produce urine specimens with this concentration of creatinine, there has been no conclusive evidence that this is a common occurrence. Concentration of creatinine at these levels is not the norm. In the interest of public safety, the DOT believes that a recollection under direct observation is a reasonable requirement. HHS Requirement That an MRO Report a Negative Result When a Medical Explanation for a Substituted Specimen Appears Legitimate The DOT proposed not adopting the HHS MRO Manual guidance for an MRO to report a negative result if the MRO believed there was a legitimate medical explanation for the substituted specimen. There were no comments related to this item. DOT Response Under part 40, the MRO will continue to have the ability to verify substituted specimens with medical explanations as cancelled tests. Because there are virtually no medical explanations for substituted results, the MRO must continue to report to DOT the medical basis for canceling the test. Section-by-Section Discussion The following part of the preamble discusses each of the final rule's sections, including responses to comments on each section. Index The DOT proposed to modify some existing section headings and add two new section headings to reflect regulation text changes. Seven section headings have been modified or added. Two commenters responded to this proposal and both supported it. Section 40.3 What do the terms in this regulation mean? In order to align more closely the definitions in Sec. 40.3 with definitions contained in the HHS Mandatory Guidelines, the DOT proposed modifying some existing definitions and adding several new ones. Commenters supported this proposal and responded by making suggested additions or changes to this section. Several commenters, especially MROs, recommended adoption of the term ``hyperdilute'' or ``superdilute'' to distinguish references to those negative-dilute specimens with creatinine concentrations in the 2-5 mg/dL range. They recommended that positive specimens the MROs downgrade to negatives be recollected if they are dilute with creatinine concentrations in the 2- 5 mg/dL range. Additionally, the terms ``cancelled-invalid'' and ``confirmatory creatinine and specific gravity tests'' are used in the text. Commenters asked if these should be included in the definitions. The DOT will modify eight definitions and add five new ones. We will include a definition of the term ``aliquot'' as defined in the HHS Mandatory Guidelines. For the term ``Oxidizing adulterant'' we did provide HHS' examples of these agents. We will not use of the term ``hyperdilute'' or ``superdilute'' to describe a dilute specimen with creatinine concentrations in the 2-5 mg/dL range. Laboratories do not report specimens with creatinine concentrations in the 2-5 mg/dL range as ``hyperdilute'' or ``superdilute'' but rather as dilute with a numerical value. To require the use of this term in the reporting process would require laboratories to change their reporting format and the DOT will not direct them to do that. Additionally, some MROs may think that the use of this term would somehow make it easier for them to report these results to the designated employer representative (DER). However, even if we adopted this term, the DERs would still have to be told that the reason for the test result being ``hyperdilute'' or ``superdilute'' is that the creatinine concentration fell in the 2-5 mg/dL range. The DOT does not think that adding a different name to a test result would in any way improve laboratory and MRO procedures. We also proposed to use the term ``cancelled-invalid'' in the NPRM. However, we will not include this term in the text since laboratories will not report tests as being ``cancelled-invalid.'' In addition, current requirements call for the MRO to check the cancelled box on the Federal Drug Testing Custody and Control Form (CCF) and, on the remarks line, write that the reason is an invalid result. We think this is sufficiently clear in describing the test outcome. We will not add another term to the current lexicon of drug testing results. We use the term ``cancelled'' in the rule text rather than ``cancelled-invalid.'' One commenter asked if a definition should be developed to describe what is meant by a confirmatory creatinine and specific gravity test. The DOT believes that the terms ``confirmatory creatinine test'' and ``confirmatory specific gravity test'' are self-explanatory and do not need more specific definitions. A confirmatory specimen validity test is just that, a test on a separate aliquot to confirm the results of an initial specimen validity test. Section 40.89 What is specimen validity testing, and are laboratories required to conduct it? The DOT will make SVT mandatory by removing the option to conduct SVT and adding text requiring SVT. This proposal had a majority of favorable comments. Specific discussion of this item is listed under Principal Policy Issues. Section 40.95 What are the adulterant cutoff concentrations for initial and confirmation tests? Section 40.96 What criteria do laboratories use to establish that a specimen is invalid? The DOT proposed adding two tables (one at the existing Sec. 40.95, the other at a new Sec. 40.96) to inform MROs and others about the cutoffs and the procedures HHS directs laboratories to use in reporting adulterated and invalid test results. We sought comments on whether this information would be helpful to MROs and others, or would have too much information and be too complicated to add value. Most commenters supported the proposal to include two tables related to adulterant and invalid testing cutoffs. The DOT, however, did not include these tables because we are concerned that including such tables could provide information useful in developing adulterants to circumvent the testing process. Moreover, the inclusion of these tables would not clarify for laboratories what they are currently required to report by the HHS Mandatory Guidelines nor would it add to the effectiveness of the MRO verification process. Since the cutoff levels are mandated by the HHS, duplicating them in the rule text does not add any value or streamline the overall procedures required by part 40. Therefore, we have indicated in the rule text that laboratories will be required to use cutoff levels for adulterated and [[Page 35965]] invalid urine specimens that are directed by the HHS. One commenter stated that an invalid report due to abnormal pH is reported only as ``abnormal pH'' per HHS direction. For the MRO to find out if it was abnormally high or low, the MRO must contact the laboratory. The commenter suggested that DOT direct laboratories to report either high pH or low pH or the actual pH numbers. This would be consistent with Sec. 40.96(d) which directs laboratories to report the reason a test is invalid and would remove the need for the MRO to call the laboratory on these results. We agree with the comment that the use of the term abnormal pH creates a requirement for the MRO to contact the laboratory, and we will therefore, direct laboratories to report the actual numerical value for pH. Finally, one commenter suggested that we clearly point out that the confirmation test is one that uses a different chemical methodology than the initial test on a second aliquot of the specimen. The definition of ``confirmatory validity test'' clearly states that a confirmation test is performed on a different aliquot of the original specimen. Section 40.97 What do laboratories report and how do they report it? Laboratories are reporting and MROs are reviewing a variety of test results, including multiple test results for the same testing event. The DOT proposed using categories to make it easier to understand what laboratories and MROs are to report. Of the commenters who responded to this proposal, some addressed only the question of categories, while others addressed issues related to multiple reporting. Several commenters agreed that understanding the myriad of results is a difficult situation and supported the DOT's attempt to simplify it through the use of identifying categories. Some concerns centered on the complexities of reporting multiple results of two separate collections from the same collection event. These commenters were troubled about how the overall process would work--for example, if two CCFs were produced on a collection, what would the MRO do with them and how would the MRO report the results? Additionally, the issue of cost per test to the employer was raised and the difficulty of billing with no documentation (i.e., no CCF for the test not reported). In any situation where the tests are reported negative and non-negative--in any order of collection--commenters agreed that the non-negative test should be the result of record reported by the MRO for the testing event. These MRO issues are addressed in the discussion of Sec. 40.162. Some commenters supported the use of categories and some did not. A number believed that laboratories would not use the categories, but would continue to use specific test results because these are more descriptive and useful. A commenter felt that the terms ``negative'' and ``non-negative'' are very simple and descriptive and much more useful than a category list. The DOT never intended for laboratories to report results as ``Category 1'' or ``Category 2'' or ``Category 3.'' In the NPRM, we merely said that a laboratory's specimen testing result would fall into one of three distinct and separate categories--negative; non-negative; and rejected for testing--and we described them as Categories 1 through 3. We agree with those commenters who said this delineation made it easier for them to understand that the results reported would fall into one of those three categories. Therefore, we will keep the three separate categories for results being reported with the understanding that laboratories are not to report a result as being in a specific category (i.e., Category 1, Category 2, or Category 3; or non- negative), but must report a specific result. Section 40.133 Under what circumstances may the MRO verify a test result as positive, or as a refusal to test because of adulteration or substitution, or as cancelled because the specimen was invalid, without interviewing the employee? MROs have situations in which neither they nor the employers are able to contact employees to complete the interview process for invalid results. The DOT proposed to modify Sec. 40.133 so that invalids would be handled parallel to part 40's directives on positive, adulterated, and substituted specimens when the employee cannot be interviewed. Four commenters responded to this proposal, and all supported the proposed procedure for resolving invalid test results without interviewing the employee. Based on the comments, the DOT will adopt the proposal in Sec. 40.133 with one modification: To refer to this result as a cancelled test due to an invalid result, instead of a cancelled- invalid. Section 40.159 What does the MRO do when a drug test is invalid? The DOT made a number of proposals trying to close the potential endless loop of observed collections that could result when the specimen result of a directly observed recollection, following a first invalid (and in some cases, a second or third observed collection), is again invalid. If the second invalid result was for the same reason as the first invalid, we proposed having the MRO cancel the test. One commenter wished to call this a negative test. The DOT believes it would be inappropriate for the MRO to call this a negative test. Therefore, we will have the MRO cancel the test if the observed recollection is invalid for the same reason as the first invalid. This is consistent with the HHS guidance to MROs. In addition, in Sec. 40.160 (see below), we have provided a way for MROs to obtain negative results for invalids when employees require negative results for pre-employment, return-to-duty, and follow-up testing. If the second invalid result was for a different reason than the first invalid, the DOT proposed having the MRO verify the result as a refusal to test. We did this to harmonize with the HHS guidance to MROs. We also proposed adding this to the list of refusals at Sec. 40.191. Many of the commenters said that calling this an automatic refusal to test is problematic--especially if this were allowed without MRO review. The DOT agrees with these commenters. We have decided not to adopt the proposal to add this to the list of refusals at Sec. 40.191. We will consider this an invalid result requiring another immediate recollection under direct observation--and we will not require the MRO to first contact the employee to discuss the result. The DOT also proposed that when the MRO reports multiple non- negative results and one of them is invalid, the MRO would not be required to report an ``invalid result'' if the MRO verified any of the other non-negative results--for example, a positive result. A number of commenters supported this proposal, but one did not understand what DOT wanted the MRO to do about the invalid result. The DOT believes that Sec. 40.159(f) is clear: When the MRO verifies multiple non-negative results and one of them is invalid, the MRO would report all but the invalid result. The invalid result simply will not be reported and the test would not be cancelled because there would actually be at least one reportable non-negative result. For instance, if a laboratory reported a test result as being positive for phencyclidine (PCP) and invalid, the MRO would conduct an MRO review for both the PCP positive and the invalid. The MRO would verify the PCP positive and report it to the employer. Even if the employee had no [[Page 35966]] medical explanation for the invalid result, the MRO would not report it to the employer unless the employee requests to have his or her split specimen tested for PCP and the split fails to reconfirm. The MRO would then cancel both tests, report them to the DER, and direct an immediate recollection under direct observation because the primary specimen had also been invalid. The same would hold true for invalid specimens whose splits failed to reconfirm for adulterants and substitutions. We also proposed to have MROs contact collection sites to confirm that collectors had properly observed the collections. We agree with the majority of commenters who said that having MROs confirm that collections had been directly observed is labor intensive and of little value, especially if CCFs indicate that observed collections were conducted. Therefore, we will not require the MRO to contact the collector. Finally, if the employee admits to using drugs to the MRO during the invalid result interview, the MRO must report the admission to the DER for additional action under applicable DOT Agency and United States Coast Guard regulations. Section 40.160 What does the MRO do when a valid test result cannot be produced and a negative result is required? The DOT proposed adding a new Sec. 40.160 to address procedures when a negative result is required but a valid test result cannot be produced because of an individual's legitimate, albeit rare, medical condition. In such rare circumstances, we will require the MRO to determine if there is clinical evidence that the individual is an illicit drug user. The evaluation requirements in this section will be parallel to existing requirements at Sec. 40.195--when a permanent or long-term medical condition precludes the employee from providing a sufficient amount of urine and a negative result is needed. If the medical evaluation reveals no clinical evidence of drug use, the MRO would report the result to the employer as a negative test with written notations regarding the medical examination. The same procedures would be used when the primary specimen is reported as invalid and the individual has a legitimate medical explanation. The DOT also requested comments about findings of illicit drug use during these medical evaluations. Currently, a finding of illicit drug use during the medical evaluation under Sec. 40.195 causes the test to be cancelled. We asked for comments on whether the DOT should continue to require cancellation or treat such findings as positive test results. Most commenters stated that findings of illicit drug use during the medical evaluation should be considered a positive result. Two commenters felt they should be reported as a refusal. One commenter stated that if the examination discloses evidence of current illicit drug use, this should be reported as a positive result. Another commenter was concerned that this evaluation may identify past drug use and may not provide the employee with due process. One commenter stated that a blood test would be far superior to a medical examination in determining evidence of substance abuse. Although a number of these commenters believe that a finding of illegal drug use during the medical evaluation should be considered a positive or a refusal, the DOT will require that in these cases, MROs will cancel the test, parallel to the existing procedures for insufficient urine in Sec. 40.195. The Omnibus Transportation Employees Testing Act of 1991 provides only one way to determine that an employee has tested positive for illicit drug use--a drug test confirmed by an HHS-certified laboratory using HHS scientific and testing protocols and verified by an MRO. Therefore, we will continue to cancel these results if there are medical signs and symptoms of illicit drug use. The individual will not be able to perform safety- sensitive duties because a negative result is needed. The MROs, under their authority at Sec. 40.327, must continue to report safety and medical qualification concerns to appropriate parties, such as the employer and the physician or health care provider responsible for determining medical qualifications of the employee. In response to the commenter who thought a blood test far superior to a medical examination for determining substance abuse, we would remind everyone that as part of this medical evaluation, the evaluating physician may conduct other testing to determine whether the employee shows clinical evidence of drug abuse, including, but not limited to, blood testing. Section 40.162 What must MROs do with multiple verified results for the same testing event? The DOT requested comments to proposed procedures addressing how the MRO would report multiple verified results from one testing event-- either multiple results from a single specimen or multiple results from more than one specimen collected during one event. Regarding multiple results from more than one specimen, we asked if it was sensible to require collectors to continue to send two separate specimen collections (e.g., a specimen that showed signs of tampering and the subsequent observed collection) to laboratories. In other words, should we continue requiring collectors to send the observed collection but not the specimen that appeared to show signs of tampering? Most commenters appreciated the fact that DOT had articulated what MROs are to report after verifying multiple results for the same testing event. Some commenters correctly noted some of the problems associated with multiple specimens collected during the same testing event. For example, these multiple specimens pose administrative difficulties: Tying together two collections and two laboratory results and simultaneously reporting the two verified results. In addition, some commenters noted that testing a second specimen imposes additional cost. None of the comments included credible evidence to show that the results of the observed collections were always non-negative. Therefore, we will continue to require that collectors send both the specimen suspected of adulteration or substitution and the directly observed specimen on for laboratory testing. At Sec. 40.67(f), collectors are already directed to identify and link both specimens in the Remarks section of the CCFs. When the collector follows the required procedures, and the MRO reviews the MRO copies of CCFs before reporting results, the MRO will know that the specimen appeared to show signs of tampering and that specimen is connected to another specimen taken under direct observation. MROs should have procedures in place to identify and connect these linked specimens. We will modify the section to authorize MROs to ``hold'' the result of the first laboratory specimen result received if it is negative until the MRO receives the result of a second specimen. If the first result is non-negative, the MRO reports it immediately. The MRO would then follow the required reporting procedures. Section 40.171 How does an employee request a test of a split specimen? The DOT proposed amending Sec. 40.171 to state clearly that there is no split specimen testing for an invalid result. This is consistent with current part 40 split request procedures and with the [[Page 35967]] HHS MRO Manual. Most commenters who responded to this item supported it. We will retain it as written in the NPRM. Section 40.177 What does the second laboratory do with the sp","truncated":true,"body_characters":99220}