# Procedures for Transportation Workplace Drug and Alcohol Testing Programs

- **operation:** document
- **citation:** 64 FR 69076
- **title:** Procedures for Transportation Workplace Drug and Alcohol Testing Programs
- **source type:** rulemaking
- **agency:** Office of the Secretary
- **status:** proposed
- **official:** true
- **published on:** 1999-12-09
- **effective on:** Not available
- **summary:** The Department of Transportation proposes to revise its drug and alcohol testing procedures regulation. The purposes of the revision are to make the organization and language of the regulation clearer, to incorporate guidance and interpretations of the rule into its text, and to update the rule to include new provisions responding to changes in technology, the testing industry, and the Department's program.
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- **source url:** https://www.federalregister.gov/documents/1999/12/09/99-31510/procedures-for-transportation-workplace-drug-and-alcohol-testing-programs
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Federal Register, Volume 64 Issue 236 (Thursday, December 9, 1999) [Federal Register Volume 64, Number 236 (Thursday, December 9, 1999)] [Proposed Rules] [Pages 69076-69136] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 99-31510] [[Page 69075]] _______________________________________________________________________ Part II Department of Transportation _______________________________________________________________________ Office of the Secretary _______________________________________________________________________ 49 CFR Part 40 Procedures for Transportation Workplace Drug and Alcohol Testing Programs; Proposed Rules Federal Register / Vol. 64, No. 236 / Thursday, December 9, 1999 / Proposed Rules [[Page 69076]] DEPARTMENT OF TRANSPORTATION Office of the Secretary 49 CFR Part 40 [Docket OST-99-6578] RIN 2105-AC49 Procedures for Transportation Workplace Drug and Alcohol Testing Programs AGENCY: Office of the Secretary, DOT. ACTION: Notice of proposed rulemaking. ----------------------------------------------------------------------- SUMMARY: The Department of Transportation proposes to revise its drug and alcohol testing procedures regulation. The purposes of the revision are to make the organization and language of the regulation clearer, to incorporate guidance and interpretations of the rule into its text, and to update the rule to include new provisions responding to changes in technology, the testing industry, and the Department's program. DATES: Comments should be received by April 7, 2000. Late-filed comments will be considered to the extent practicable. ADDRESSES: Comments should be sent to Docket Clerk, Attn: Docket No. OST-99-6578, Department of Transportation, 400 7th Street, SW., Room PL401, Washington DC, 20590. For the convenience of persons wishing to review the docket, it is requested that comments be sent in triplicate. Persons wishing their comments to be acknowledged should enclose a stamped, self-addressed postcard with their comments. The docket clerk will date stamp the postcard and return it to the sender. Comments may be reviewed at the above address from 9:00 a.m. through 5:30 p.m. Monday through Friday. Commenters may also submit their comments electronically. Instructions for electronic submission may be found at the following web address: http://dms.dot.gov/submit/ .. The public may also review docketed comments electronically. The following web address provides instructions and access to the DOT electronic docket: http:// dms.dot.gov/search/ . FOR FURTHER INFORMATION CONTACT: Mary Bernstein, Director, Office of Drug and Alcohol Policy and Compliance (ODAPC), 400 7th Street, SW., Room 10403, Washington DC, 20590, 202-366-3784 (voice), 202-366-3897 (fax), or [email protected] (e-mail); Robert C. Ashby, Deputy Assistant General Counsel for Regulation and Enforcement, 400 7th Street, SW., Room 10424, Washington DC, 20590, 202-366-9306 (voice), 202-366-9313 (fax), or [email protected] (e-mail); or Jim L. Swart, Drug and Alcohol Policy Advisor, Office of Drug and Alcohol Policy and Compliance (ODAPC), 400 7th Street, SW., Room 10403, Washington DC, 20590, 202-366-3784 (voice), 202-366-3897 (fax), or [email protected] (e-mail). SUPPLEMENTARY INFORMATION: Background The Department of Transportation first published its drug testing procedures regulation (49 CFR Part 40) on November 21, 1988 (53 FR 47002), as an interim final rule. The rule was based on the Department of Health and Human Services (HHS) guidelines for Federal agency employee drug testing, with some adaptations for the transportation workplace drug testing program. The Department published a final rule responding to comments on the interim rule a year later (54 FR 49854; December 1, 1989). The Department added alcohol testing procedures to Part 40 in a February 15, 1994, final rule (59 FR 7340). This rule also modified drug testing procedures pertaining to split samples. Since that time, the Department has amended specific provisions of Part 40 on various occasions (e.g., with respect to non-evidential alcohol screening devices, ``shy bladder'' procedures). In the 10 years since Part 40 was first published, the Department has issued a large volume of guidance and over 100 written interpretations, as well as a significant amount of informal advice. Most of this material has not been incorporated into the regulatory text. There have been changes in testing technology, the structure of the drug and alcohol testing business, and the functioning of the Department's drug and alcohol testing programs, making it desirable to update some regulatory provisions. Because the rule was originally based on that of another agency, there are some provisions that never were a close fit for the Department's programs. Moreover, the rule's organization and language do not meet the objectives of the Clinton Administration's current ``Plain Language'' policies. Under section 610 of the Regulatory Flexibility Act, agencies are directed to review existing rules from time to time with an eye to their effects on small businesses and other small entities. For all these reasons, the Department decided to review Part 40. As a first step, we issued an advance notice of proposed rulemaking (ANPRM) on April 29, 1996 (61 FR 18713), asking for suggestions for change in the rule. We received 30 comments in response to this ANPRM. Organization of Draft Perhaps the first thing readers will notice about this proposal is that Part 40 has been thoroughly restructured, with subparts organized by subject matter area. Compared to the present rule, the text is divided into many more sections, with fewer paragraphs each on average, to make it easier to find regulatory provisions. The proposal uses a question-answer format, with language specifically directing particular parties to take particular actions (e.g., ``As an MRO, you must . . .''). We have also tried to express the (admittedly sometimes technical) requirements of the rule in plain language. The Department seeks comment on the clarity, format, and style of the NPRM and solicits suggestions for improving it. Noteworthy Substantive Changes Proposed The following section of the preamble lists the NPRM's most noteworthy proposed substantive changes from the existing rule and briefly states the reasons for them. Interpretations/Exemptions To avoid confusion and the possibility of overlapping or contradictory guidance, Sec. 40.5 spells out specifically the sources and dates of authoritative guidance of the proposed rule. Guidance would come from the Office of the Secretary (OST), either ODAPC or General Counsel's office. It could later be incorporated in written guidance issued by the DOT agencies, though it would be identified as ODAPC/General Counsel's office guidance. Since this proposal is intended to lead to a revised regulation, the language states that only post-issuance guidance or interpretations are valid, since earlier material pertains to the old version of the rule. ODAPC intends to follow a practice of putting new Part 40 interpretations and guidance on the DOT Web site for users' convenience. This is an OST rule. Therefore, anyone wanting an exemption from it would use the procedures and standards of 49 CFR Part 5, OST's rulemaking procedures. These procedures, rather than those of any of the DOT agencies, would apply to such a request. The proposed section spells out the long-standing procedures of Part 5 for granting an exemption. These standards are intended to preclude ``rulemaking by exemption,'' which is contrary to good rulemaking practice and the Administrative Procedure Act. [[Page 69077]] Service Agent Assurance Proposed Sec. 40.11 includes new provisions that call for both regulated employers and their service agents to sign a contract provision committing them to compliance with Part 40 provisions. ``Service agent'' is a new term, intended to encompass participants in the testing process other than employers themselves (e.g., medical review officers (MROs), substance abuse professionals (SAPs), collectors, laboratories, third-party administrators). The Department is using ``service agent'' as a working term for this collection of participants who provide testing-regulated services to employers. The Department invites suggestions for other terms for this group of service providers. NRC Procedures In response to a comment from the Nuclear Regulatory Commission (NRC), the proposed rule would permit an entity which has employees covered by both DOT and NRC testing requirements to use either agency's procedural requirements. Prohibition of Additional Testing This section places a number of long-standing DOT interpretations into the regulatory text. It proposes to say that there must be a firewall between DOT and non-DOT tests, which extends to the use of Federal forms for non-DOT tests. Tests not expressly authorized by DOT rules on ``DOT specimens'' are forbidden (e.g., tests for additional drugs, DNA tests). Nor can anyone take into account an unauthorized test (e.g., in a situation in which an employee with a positive test obtains a test result from his own doctor that he attempts to use in a grievance proceeding). The rule text omits current language permitting testing of additional drugs with DOT and HHS regulatory consent. HHS has never authorized any additional drugs. If additional drugs are authorized, the Department can amend the rule at that time. Collector Training While current Part 40 has specific training requirements for screening test technicians (STTs) and breath alcohol technicians (BATs) in the alcohol testing program, it does not have analogous requirements for drug testing collectors. The Department is also aware that mistakes in the collection process are generally regarded as being a common cause of problems in the drug testing process. Consequently, the Department proposes in Sec. 40.33 that collectors read and understand DOT rules and guidance concerning collections, demonstrate proficiency by completing three consecutive error-free trial collections, and receive retraining as needed. The Department seeks comment on whether self-instruction is adequate for this purpose or whether more formal training should be required (e.g., a specified course with a certification requirement, as is the case for STTs and BATs). In this and several other contexts, we propose to require individuals who are training or evaluating participants in the testing process to be ``sufficiently knowledgeable'' about testing requirements and procedures. We recognize that this term does not precisely define the experience and information the individual must possess. Our aim in using this language is to ensure that people involved in the training process know what they need to know to judge fairly whether a collector, BAT, etc. has grasped the essentials of the function. It is not our intent, however, to require formal instruction or a standard curriculum for trainers. Doing so could increase costs and make the program unnecessarily rigid. We seek comment on whether a different term or other requirements would be appropriate in this area. Drug Testing Forms and Materials The NPRM proposes (Secs. 40.47 and 40.49) that no one can use a DOT drug testing form for a non-DOT test or vice-versa. However, because obtaining a test result is the more important factor, use of a non-DOT form for a DOT test is, in cases where a look-alike form is used, a correctable error in the testing process. Collectors also must use a testing kit conforming to DOT requirements (see Appendix A for additional information on the kit). This proposal is based on our experience and a thorough review of testing kits by DOT staff. The Department also seeks comment on what, if any, additional security measures would be appropriate for testing materials and supplies. The proposal (Sec. 40.45(e)) also would continue existing policy that foreign employers can use foreign-language versions of the forms (e.g., Spanish in Mexico, French in Canada). Should U.S. employers also be permitted to use these or other foreign-language versions of the forms? If this is allowed, additional questions may arise (e.g., should a foreign-language form be used only when both collector and employee understand the language?). HHS is presently revising that form and has published it for public comment in a Notice of Proposed Revision in the Federal Register [November 15, 1999 (Volume 64, Number 219)]. We will not publish, in this NPRM, copies of the HHS-proposed Federal Drug Testing Custody and Control Form (CCF) or the CCF currently in use. (Nor will we publish the Breath Alcohol Testing Form (BATF) currently in use.) Electronic Records and Signatures From time to time, interested parties have raised, and the Department has sought comment about, the potential use of electronic records and signatures in the DOT drug and alcohol testing program. The regulatory text of this NPRM does not make any new proposals in this area. However, the Department is willing to consider ideas that would, to a greater degree than is currently the case, permit the use of electronic records and signatures in the program. We are also aware that other Federal agencies have taken steps to encourage greater use of electronic records and signatures. For example, the Food and Drug Administration (FDA) issued rules to this effect (62 FR 13430; March 20, 1997). The FDA rules authorize electronic signatures in many documents submitted to the agency, with a number of safeguards designed to ensure the reliability and trustworthiness of the signatures. The Department again seeks comment on the potential applications, advantages, risks, and safeguards for the use of electronic signatures and the greater use of electronic records in the DOT drug and alcohol testing program. For example, are there electronic ``stamping'' mechanisms we should permit for use with the CCF? Collection Process Section 40.61 incorporates a number of provisions that are new or based on existing interpretations (e.g., collections are to begin without delay, it is improper to attempt to collect urine from unconscious employees, collectors can inspect boots for adulterants). Sections 40.63-65 provide a step-by-step process for collectors for the initial stages of the collection process. Collection steps concerning completion of the CCF are written in this NPRM based upon the collector's use of the current Federal form. When HHS approves use of a new form, the Department will modify Part 40 collection steps (as well as laboratory and MRO responsibilities for completion of the CCF) accordingly. The proposed rule would stipulate that in the event an employee, after presenting an insufficient amount of urine, refuses to drink fluids as directed by the collector, the collector is to stop [[Page 69078]] the collection proceedings. A failure to drink as directed would constitute a refusal to test (Secs. 40.191(a)(5) and 40.193(b)(2)). The Department seeks comment on this proposal. Should the collection be curtailed at this point and the refusal to test be the final result? Or, should the employee have up to three hours to present a complete specimen, with the ``shy bladder'' procedures taking place if the employee subsequently fails to provide the required amount of urine? Directly Observed and Monitored Collections In Secs. 40.67 and 40.69, the NPRM consolidates in one place the requirements concerning directly observed and monitored collections, respectively. The language states that an immediate collection under direct observation would be called for in some situations involving unsuitable specimens or when a previous test has been canceled because of the unavailability of a split specimen. The Department seeks comment on whether we should also require an immediate recollection under direct observation if an employee's specimen is dilute. We also seek comment on whether employers should be permitted the ability to reject a negative test result when a specimen is reported negative but dilute by the MRO. Currently, the rules permit an employer to have the employee's next test to be collected under direct observation, but this opportunity may not occur for months. The proposal notes that a refusal to permit a directly observed or monitored collection has the same effect as any other refusal to test. The NPRM clearly distinguishes between the activities of an observer (e.g., who actually watches the urination) and a monitor (who stands by and listens but does not watch). Laboratories Some laboratory-related material (e.g., present Sec. 40.27, concerning personnel) would be deleted, as unnecessarily duplicative of the HHS guidelines. The NPRM would make laboratories subject to public interest exclusions if they failed to comply with DOT rules, even if their HHS certification remained intact (Sec. 40.81(c), (d)). The Department asks for comment on whether, in the case of an amphetamine positive, the laboratory should perform a d-and l-separation in all cases. For the first time, laboratories would be required to test for nitrites, pH, creatinine and, in certain circumstances, specific gravity (Sec. 40.91). This so-called ``adulteration panel'' would increase the ability of the testing process to catch attempts to cheat. We note that, under HHS guidance for the Federal agency personnel testing program, these tests are discretionary. We seek comment on the advantages, disadvantages, costs, and benefits of mandatory adulterant testing. In addition, the NPRM contains largely new procedures for dealing with unsuitable specimens and situations in which a split specimen does not reconfirm the result of the primary specimen (Secs. 40.151 and 40.177). The rule text, like that of the present rule, is silent on the issue of who selects a laboratory for testing. From the Department's point of view, any HHS-certified laboratory will do. The selection of the laboratory can be made by the employer, or it could be made as a matter of collective bargaining where applicable. In any case, the laboratory must be suitable to the employer. To reduce paperwork and save time in the process, laboratories would no longer have to routinely send original copies of certain copies of the drug testing form to the MRO. The MRO would request original copies if, for example, faxed copies were unclear. The proposed rules (Secs. 40.83 and 40.155) would also clarify under what circumstances a laboratory may reject a specimen for testing and one circumstance that they must reject a specimen for testing. The Department seeks comment on the length of time laboratories should maintain rejected specimens. In addition, the rules delineate the laboratory reporting requirements as well as the role of the MRO in ruling out collector error as being the causative factor. MRO reporting requirements are highlighted. DOT seeks comments on the viability of having the employee return for a second collection if collector error results in a laboratory's rejecting a specimen for testing. In its implementation of the existing rule, the Department has identified a number of situations that potentially present conflicts of interest or their appearance. In a number of cases, the Department has provided guidance to employers and service agents that these practices are inappropriate. Examples of such practices are: the laboratory employs the MRO; the laboratory has a contract or retainer with the MRO; the laboratory designates which MRO the employer is to use, gives the employer a slate of MROs from which to choose, or refers the employer to or recommends certain MROs; the laboratory gives the employer a discount or other incentive to use a particular MRO; the laboratory has its place of business co-located with that of the MRO; the laboratory derives a financial or other benefit from having an employer use a particular MRO; and the laboratory permits an MRO, or an MRO's organization, to have a significant financial interest in the laboratory. It should be noted that problems of this kind arise when a laboratory has a relationship with an MRO who reviews the laboratory's DOT test results. The Department seeks comment on whether the text of the final rule should, in order to provide clear notice to affected parties, provide a specific list of prohibited practices. If so, should the items above be part of such a list? Should items be added or deleted? We are also interested in your comments on what limitations, if any, should be placed on laboratories and MROs serving as third-party administrators or collection sites, and what conflict of interest issues these relationships may raise. The NPRM would require each laboratory to sign a certification that there exists no conflict of interest or the appearance of conflict of interest between the laboratory and any MRO to whom they transmit DOT test results. In the absence of regulatory specification of the nature of such conflicts, is this proposed requirement meaningful or enforceable? For enforcement purposes, would it be useful for a laboratory to maintain a list of the MROs to whom this certification applies? Laboratory Reports 49 CFR Part 40, published December 1, 1989, contained the same requirements for the laboratory summary report (monthly at that time) as the requirements contained in the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (i.e., the number of specimens received, screened positive, and the number that subsequently confirmed positive, by type of drug). An amendment to Part 40, published August 19, 1994, changed the original requirement for monthly reports to quarterly, clarified authority for laboratories to provide these reports to consortia, and changed the type of information that should be included by deleting the requirement for screening results. One of the Department's concerns underlying this change was to avoid the potential for identifying individuals who may have been positive, but whose results were subsequently ``downgraded'' based on medical use. This issue is important in that if laboratories report confirmed laboratory positive results by type of test (e.g., pre-employment, reasonable suspicion), the potential exists to [[Page 69079]] identify individuals, even if there are more than five tests results listed on the report. The following chart compares current DOT and HHS laboratory report requirements: ------------------------------------------------------------------------ DOT HHS ------------------------------------------------------------------------ Initial Testing: Initial Testing: 1. Number of samples received for 1. Number of samples testing. received. 2. Number of samples reported out. 3. Number screened positive for: A. marijuana metabolites. B. cocaine metabolite. C. opiate metabolites. D. phencyclidine. E. amphetamines. Confirmatory Testing: Confirmatory Testing: 1. Number received for confirmation. 2. Number confirmed positive for: 2. Number confirmed positive for: A. marijuana metabolites....... A. marijuana metabolites. B. cocaine metabolite.......... B. cocaine metabolite. C. opiate metabolites.......... C. opiate metabolites. D. phencyclidine............... D. phencyclidine. E. amphetamines................ E. amphetamines. F. methamphetamines. 3. Number for which test was not performed. ------------------------------------------------------------------------ DOT and HHS agree that the laboratory summary reports required by each agency should be the same. This would minimize additional paperwork that laboratories would be subjected to in providing two different reports. Additionally, deleting the HHS requirement to report screened results would lower the laboratory workload and shorten the report. Currently, there is no requirement for laboratories to report to employers the number of tests received by the laboratory by type of test (pre-employment, random, etc.). However, it appears that many employers want this information, thinking that it could be used as a check on their own statistical data. Large employers and service agents generally maintain appropriate statistical data for their programs and the Department is interested in hearing from the industry if this type of additional information from the laboratories is truly helpful. The Department would also like to know if information identifying the number of specimens that must be canceled and/or are adulterated would be useful to employers, service agents, or in the overall enforcement process. Please note that the requirements would be for submission of the report on a monthly basis under HHS regulations and semi-annually under the proposed DOT rules, with more frequent reporting as required by the Federal agency with regulatory authority over the employer. The Department also seeks comment on record retention requirements for laboratories (see Sec. 40.109). Are the proposed record retention periods appropriate? Should any of the periods be lengthened or shortened? Blind Specimens Current rules require employers to send ``blind'' urine specimens to laboratories for drug testing. These samples are unannounced and are made to look like normal samples. Whether they are negative or positive (and for which drugs) is known in advance only by the senders. These specimens are used to test the accuracy of the laboratory testing system. Together with other quality control procedures, blind specimens are an important means of keeping the testing program legitimate in the eyes of the courts, congress, and employee groups. Currently, all employers must send these samples to the respective laboratories they use. The NPRM, in the interest of reducing burdens on regulated parties, would reduce blind specimen requirements from current levels (Sec. 40.103). Parties with fewer than 2000 DOT covered employees would no longer have to provide blind specimens (Sec. 40.103(a)). For other parties, blind specimens would only have to be provided at a one percent rate, up to a cap of fifty blind specimens per calendar quarter. This change is intended to be helpful to small businesses. In addition, since consortiums that send in large numbers of specimens collected from a variety of employers will continue to have to submit blind specimens, we do not expect that this change will adversely affect the accuracy of the laboratory testing process. The Department seeks comment on whether the blind specimen requirement should be eliminated entirely or modified in a different way from the NPRM proposal. The proposed language provides examples of how the blind specimen requirements would work. Section 40.105 would specify what happens if there is a laboratory error on any specimen, to include a blind specimen. In addition, we ask whether testing blind specimens for adulterants is warranted. MRO Training and Responsibilities MROs would have to take a training course every two years or certify that they have reviewed and understand Part 40 and applicable DOT agency regulations and guidance. The NPRM also sets out a list of MRO responsibilities, including acting as an independent ``gatekeeper'' for the accuracy and integrity of the testing process and correcting and reporting problems when they are found (Sec. 40.123). It is particularly important that MROs not be involved in relationships with laboratories that could create a conflict of interest or the appearance of such a conflict. There are proposed conflict of interest requirements for MROs parallel to those for laboratories (Sec. 40.125). The Department wishes to emphasize its view that the MRO is a very important player in the testing process, who more than any other person is responsible for maintaining the integrity of that process. It is the MRO's responsibility to advocate for and defend the accuracy of the process. This part of the MRO's role makes a conflict [[Page 69080]] of interest especially sensitive. These issues are not necessarily limited to MRO/laboratory relationships. Given the MRO's role as an evaluator of the testing process, does the MRO's ownership or administration of a collection site create the appearance or reality of a conflict of interest? The rule, at various points, sets time frames for certain actions by MROs (e.g., 14 days for verifying a ``non-contact positive'' in Sec. 40.133(a)(2)). Should such time frames be expressed in ``business days'' (i.e., excluding weekends and holidays) rather than calendar days? It is common for MROs to conduct their functions across state lines. An MRO located in one state may perform functions concerning drug tests and employees located in many other states. Recently, we have learned of some concerns that some state medical licensing agencies may believe that out-of-state MROs who are not licensed to practice in the state may not be authorized to perform MRO functions with respect to employees located in the state. The Department is interested in learning whether this is a significant issue, and if so whether the issue poses a serious obstacle to the performance of MRO functions in a national safety program. If there is such a problem, should the Department take regulatory action to address it? If so, what action would be appropriate? MRO Reviews of Test Results The Department believes that it is important to draw a clear distinction between the roles of the MRO, on one hand, and the MRO's staff, on the other. MROs are responsible for supervising their staffs (see for instance Sec. 40.127(a)). When MRO staff review test result documents, MROs would personally have to oversee their work, including direct re-review of a portion of the documents they have reviewed. Staff members can handle administrative contacts with employees and remind them to have medical information ready for their MRO interviews, but actually gathering medical information and drawing conclusions from the information would be the personal responsibility of the MRO (see for instance Sec. 40.131(b)). The ways a MRO makes use of a designated employer representative (DER) to contact a difficult-to-find employee are also spelled out in greater detail than in the present rule. In response to a number of requests, the proposal would define a reasonable time for a DER to contact an employee as two attempts over a 24-hour period. The rule (Sec. 40.133(a)(2)) would also authorize MROs to verify a test positive if neither the MRO nor the DER had been able to contact the employee within 14 days of the MRO's receipt of the confirmed positive test result. The Department seeks comment on whether this time period is appropriate, or a longer or shorter period should be used. The MRO provisions of the NPRM contain proposed language consistent with the Department's discussion of the ``stand-down'' issue (see ``Employer Actions'' below). The MRO provisions in the proposed regulatory text would prohibit MROs from telling or, in the alternative, permit MROs to tell, the employer for whom the MRO is working that the MRO has received a laboratory confirmed positive test result, pending the completion of the MRO verification process (Sec. 40.129(d)). The rule text will contain both options. MRO Verification Process Section 40.135 lists explicitly what MROs would have to tell employees at the beginning of the verification interview, including warnings about the effect of the refusal to provide information for a medical evaluation (see Sec. 40.135(c)) and that the MRO may provide medical information to employers or others under some circumstances. Sections 40.137 and 40.139 distinguish between the burdens of proof applicable to opiates and to all other drug types. The MRO bears the burden of showing unauthorized use of opiates, while the employee bears the burden of showing that there was a legitimate medical explanation for the presence of other drugs. The MRO would have to offer the employee the chance to provide a legitimate medical explanation. The Department seeks comment on whether an exception to this rule should be made in the case of PCP, for which there are no known legitimate medical applications. In making a verification of the unauthorized use of opiates, the MRO may consider such factors as needle tracks, behavioral or psychological signs of acute addiction, clinical history of unauthorized use (including admissions by employees), or use of foreign medication without substantiation that the medication was obtained and used legally. It should be emphasized that the MRO is intended to exercise good professional judgment on a case-by-case basis; the rule does not mandate a finding of positive or negative on the basis of any particular piece of evidence (aside from a laboratory finding of the presence of 6-AM). In the case of opiate verifications, the Department seeks comment on whether it would be appropriate to shift the burden of proof in cases of very high opiate levels. That is, if the quantity of opiates in a specimen is very high (i.e., at or above 15,000 ng/mL), making an innocent-ingestion explanation (e.g., poppy seed bagels) very unlikely, then the employee would have the burden of proving that there was a legitimate medical explanation (e.g., a prescription medication) for the laboratory positive. In such a situation, the verification process for high levels of opiates would work like the verification process for other drugs. The proposed rule text incorporates this approach. In reaching this decision, the Department reviewed a number of scientific studies of food products containing poppy seeds. While most studies found concentrations of 5,000 ng/mL or below, in only one study (C. M. Selavka. ``Poppy seed ingestion as a contributing factor to opiate- positive urinalysis results: the Pacific perspective.'' Journal of Forensic Sciences, 1991;36(3):685-696.), did a product show concentration above 5000, this one at 11,571 ng/mL. Is our level of 15,000 ng/mL (which is approximately thirty percent above any known concentration attributable to poppy seed ingestion) too high or too low? MROs are cautioned against considering evidence from unauthorized sources (e.g., non-DOT urine tests, blood tests, hair tests, DNA tests) and evidence outside the test documentation (e.g., an employee's assertion that the documents do not accurately reflect what happened at the collection site). MROs are also cautioned against considering ``innocent ingestion'' defenses (e.g., ``Someone slipped the drug into my drink at the party;'' ``I ate a hemp product;'' ``I was hanging out with people who were smoking funny-looking cigarettes'') that, even if true, do not constitute a legitimate medical explanation for the presence of a drug in an employee's specimen (Sec. 40.143). This is also true of statements by an employee that he or she has used marijuana for medical purposes in a state that has a so-called ``medical marijuana'' law. Use of marijuana on the basis of a doctor's prescription or recommendation does not constitute a legitimate medical explanation that is sufficient to permit an MRO to verify a test as negative. Use of a hemp product is not a legitimate medical explanation, either. In the context of pre-employment testing, the NPRM states that a person with a permanent or long-term disability preventing him or her from providing a sufficient specimen may be regarded as testing negative. In such a case, the individual must undergo a medical examination to determine if the individual is free of signs or symptoms [[Page 69081]] of illegal drug use. The Department seeks comment on whether a similar provision should be created to apply to other types of testing. For example, if an individual has this type of permanent or long-term disability, should the individual undergo a medical examination to determine if he or she is free of signs or symptoms of drug abuse in lieu of a futile attempt to complete a random drug test in the usual way? This would avoid the necessity of going through the ``shy bladder'' procedure repeatedly, while providing a surrogate for the drug test that could accomplish the safety goal of testing. One of the most common misunderstandings of the current rule is that an employee who makes a timely request for the test of a split specimen (where such testing is mandated by statute) may be denied such a test if he or she does not pay for it up front from his or her own funds. To avoid this problem in the future, Sec. 40.145 specifies that an MRO must explicitly inform the employee that, if he or she has a verified positive test and asks for a test of the split specimen in a timely manner, the test will be performed, regardless of whether the employee complies with a request from a laboratory, employer, or other party to pay for it in advance. While the rule is intentionally silent on who ultimately pays for a test, the employer is responsible for ensuring the test occurs. (See also Secs. 40.171 and 40.173.) The text also proposes that MROs can conduct the verification process and report results if the MRO has received legible copies of the MRO and laboratory copies of the CCF. The text also delineates an MRO's responsibility in pre-employment testing situations when the employee has a disability preventing the submission of a urine specimen. Adulterated, Substituted, and Dilute Tests This NPRM proposes to mandate testing for adulterated and substituted specimens (``validity testing''), which will likely increase the number of situations in which laboratories determine that a specimen has been adulterated or substituted. This proposal is based on the concern that adulteration and substitution are real and possibly increasing threats to the integrity of the Department's drug testing program, with the potential for increased safety risks if drug users succeed in frustrating the testing process. The proposed rule (Sec. 40.93) sets forth standards and a process for determining when a specimen is adulterated, substituted, or dilute. For substituted and adulterated specimens, the proposed rule, consistent with HHS guidance, requires laboratories to test two different aliquots of the primary specimen. In many cases, the laboratory must use different procedures, at least one of which is quantitative, for each of the aliquots. Only then does the laboratory determine that the specimen is substituted or adulterated. The requirement to test two different aliquots is designed to ensure that the laboratory makes such a determination only on the basis of a reproducible result. This is an important safeguard for the accuracy of the process. DOT policy provides that an individual who has been found to have adulterated or substituted a specimen is viewed as having refused to test. Such a refusal is a violation of DOT agency regulations, with consequences similar to those of a positive test. That is, an employee who refuses to test is prohibited from performing safety-sensitive functions unless and until he or she completes the return-to-duty process. Under some DOT agency regulations (e.g., the FRA), the consequences of a refusal to test can be more stringent than those of a positive test. There are also some employer policies that treat refusals more strictly than positive tests. The increased prominence of testing for adulteration and substitution of specimens, combined with the seriousness of consequences for refusing to test, has resulted in increased interest in safeguards for employees. In particular, some unions and other parties have suggested that the Department should apply split specimen testing procedures to specimens that have been found to be adulterated or substituted. This suggestion grows out of a requirement in the Federal Motor Carrier Safety Administration (FMCSA) [prior to January 1, 2000, the Federal Highway Administration], the Federal Transit Administration (FTA), the Federal Railroad Administration (FRA), and the Federal 
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