WAIS Document Retrieval[Federal Register: December 9, 1999 (Volume 64, Number 236)] [Proposed Rules] [Page 69075-69136] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr09de99-22] [[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 [[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 mary.bernstein@ost.dot.gov (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 bob.ashby@ost.dot.gov (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 jim.swart@ost.dot.gov (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 Aviation Administration (FAA) testing rules that employees who test positive for drugs are entitled to ask for a test of a second, or ``split,'' specimen at a second laboratory to confirm the presence of the drug. This requirement is mandated by provisions of the Omnibus Transportation Employee Testing Act of 1991. In the Research and Special Programs Administration (RSPA) and United States Coast Guard (USCG) programs, which are not covered by the Omnibus Act, split specimens are optional with employers. The Department is seeking comment on three options concerning this issue. The first option is to do nothing beyond the procedure set forth in the regulatory text, in which there would be two separate tests of the primary specimen before a finding of substitution or adulteration is made. The Department is confident that this option is legally defensible. It also is less costly and less prone to the possibility of administrative error than a system involving testing of the split specimen. Split specimen testing, even in the context of positive drug test results, is not constitutionally mandated. The Department's drug testing rules, prior to the 1994 amendments implementing the Omnibus Act, left split specimen testing to the discretion of employers. The Department's drug testing requirements and procedures were upheld as constitutional by the courts before those amendments were made. It is not reasonable to assert that the Department is constitutionally required to expand the application of a procedure which is not constitutionally required to be used in the first place. Nor is split specimen testing required by the statutes and regulations governing the Department drug testing programs. The split specimen provision of the FMCSA, FTA, FRA, and FAA rules results from a requirement of the Omnibus Transportation Employee Testing Act of 1991 (49 U.S.C. Sec. 5331(d)(5)). This section provides that: . . . each specimen be subdivided, secured, and labeled in the presence of the tested individual and that a part of the specimen be retained in a secure manner to prevent the possibility of tampering, so that if the individual's confirmation test results are positive the individual has an opportunity to have the retained part tested by a 2d confirmation test done independently at another certified laboratory if the individual requests the 2d confirmation test not later than 3 days after being advised of the results of the first confirmation test. [emphasis added] This provision is implemented in the Department's current drug testing procedural regulations: . . . the MRO shall notify each employee who has a confirmed positive test that the employee has 72 hours in which to request a test of the split specimen, if the test is verified as positive. . . . If the [second laboratory's] analysis fails to reconfirm the presence of the drug(s) or drug metabolite(s) found in the primary specimen, . . . the MRO shall cancel the test. . . . [49 CFR Sec. 40.33(f); emphasis added] In the first instance, both the statutory and regulatory language create a right to a test of the split specimen only in situations where there is a confirmed [[Page 69082]] positive test. A confirmed positive test occurs only when the laboratory confirmation test detects sufficient quantities of the specified drug(s) or drug metabolite(s). In a case where the laboratory has found an adulterant in the specimen or has determined it to be substituted, the laboratory does not report a confirmed positive test to the MRO. The condition precedent to the right to a second confirmation test has not occurred, since there has never been a confirmed positive test for a drug reported to the MRO in the first place. The current regulation, in spelling out the procedure for requesting a test of a split specimen, provides that a request must be made within 72 hours of a verified positive test. (The MRO verifies a confirmed laboratory test as positive if the MRO cannot determine that there is a legitimate medical explanation for a laboratory confirmed positive test result.) In the absence of a confirmed positive test, there can never be a verified positive test, which is the trigger for the employee's opportunity to request a test of the split specimen. The current regulation further provides that if the test of the split specimen fails ``to reconfirm the presence of the drug(s) or drug metabolite(s) found in the primary specimen,'' the test must be canceled. In a case involving a finding of adulteration or substitution, there has never been a reported finding that drug(s) or drug metabolite(s) are present in the employee's specimen. One cannot ``reconfirm'' a finding that has never been made. The regulation requires cancellation of a test only if the presence of drug(s) or drug metabolite(s) is not reconfirmed in the split specimen. In addition to the use of split specimen testing in adulteration or substitution cases not being legally required, the first option is supported by three policy considerations. First, the Department is very concerned that present adulterants and other interfering substances may degrade over time. That is, when an adulterant is present in the primary specimen but degrades chemically to the point where it cannot be detected or changes to another chemical state in the split specimen (e.g., HHS has recently identified one adulterant that appears to degrade in a matter of hours), our making split specimen testing available for adulterants could help drug users ``beat the test.'' In addition, manufacturers of commercial products intended to defeat drug testing--who engage in a well-publicized ``arms race'' to find new means of defeating drug tests--may well be able to develop, in the future, adulterants that degrade even faster. Second, the Department's experience is that the overwhelming majority of test cancellations related to split specimens result from collection or logistical problems (e.g., collector fails to collect the split specimen, a split specimen is lost or leaks in transit). The Department has been reluctant to expand the application of split specimen testing to areas where it is not required by statute, which could have the result of canceling otherwise valid tests and allowing drug users to continue to perform safety-sensitive functions. Third, the Department has viewed an adulterated or substituted specimen as more closely analogous to a refusal to test than to a positive test. Employee A flatly tells the collector that he will not provide a specimen, or simply does not show up for the test. Employee B shows up, provides a specimen, signs the statement on the custody and control form certifying that he or she has not tampered with the specimen, but nevertheless puts a substance into the specimen that prevents the laboratory from testing it. The actions of Employee A and Employee B are equivalent. Having a second opportunity to defeat the testing process is no more appropriate for Employee B than for Employee A. The second and third options would both add a further element to the language in the proposed regulatory text. The Department seeks comment on all three options, as well as any other suggestions commenters may have on this subject. The second option would be to treat an adulterated or substituted test result the same as a verified positive and allow the employee to request a split specimen test by a second laboratory. For example, suppose a laboratory makes an adulteration or substitution finding. Within 72 hours of being informed of the finding, the employee would have the opportunity to request a test of the split specimen by the second laboratory to see if the adulteration or substitution finding could be reconfirmed. If it were not reconfirmed, the test would be canceled, just as in the case where a split specimen fails to reconfirm the presence of a drug or metabolite found in a positive primary specimen. This option would ensure that employees who face similar or more severe employment consequences compared to employees with positive tests for drugs have an equal ability to challenge a laboratory's primary specimen determination. The argument in favor of this approach is basically one of fairness. This additional safeguard for the fairness of the process could provide reassurance to the vast majority of employees who fully and honestly cooperate in drug testing programs. It could also discourage frivolous challenges to drug test results by employees who know they have submitted adulterated samples. In addition, more research needs to be done in the area of adulterants degrading over time. There are technical questions that need to be resolved about the protocols and standards to be applied in split specimen reconfirmation in adulteration and substitution situations. The Department is working with HHS to ensure that this information is available in time for the final rule. Meanwhile, we invite comment on the technical and scientific issues concerning adulteration and substitution testing and reconfirmation. The Department seeks comment on whether, if a provision for split specimen testing for adulterated and substituted specimens is included in the final rule, it should be required or optional. That is, should we require employers to make split specimen testing available in these circumstances, or should employers (or employers and unions, where collective bargaining agreements apply to drug testing issues) have the choice of whether to make split specimen testing available? In addition, we seek comment on whether Part 40 should also be amended to require employer submissions of adulterated and substituted specimens as part of the external quality control (``blind specimen'') program. If so, how should selection of adulterants be made? How many adulterated specimens should be included within the minimum number of blind specimens submitted? To what extent have such specimens been included in existing blind testing programs? What practical issues could arise with regard to administration of such a program? A third option occupies a middle ground between the first two options. When a laboratory finds that a primary specimen has been adulterated or substituted, it would immediately test a third aliquot of the same specimen to see if the same result was obtained (two aliquots would already have been tested before the original finding of adulteration or substitution had been made). If the retest did not confirm the original finding, the test would be canceled. The Department seeks comment on what the standards should be for this additional test. For example, should we set a standard that to be regarded as confirming the presence of an adulterant, the additional test result should be within +/-20 percent of the [[Page 69083]] original result (while still satisfying the initial reporting criteria)? This approach would add a safeguard for employees, by adding another level of assurance that the laboratory was relying on a reproducible result. Reproducibility is a key component of the validity of any scientific process, and this approach would ensure that no one would suffer adverse consequences on the basis of a result that could not be reproduced. Since the retest would occur immediately, degradation of most adulterants would not be a major problem. In addition, because it would take place in the same laboratory and would not involve the split specimen, collection or transmission errors affecting the split specimen would not result in the cancellation of an otherwise valid adulteration or substitution result. Finally, the proposed rule text includes material adapted from the DOT and HHS guidance concerning other types of ``problem tests'' (Secs. 40.147 through 40.153). As current DOT guidance states, a retest under direct observation is required in situations of some ``unsuitable'' specimens. The Department seeks comment on whether a retest under direct observation should also be required in cases of dilute specimens. The Department also seeks comment on a frequently- asked question about dilute specimens: should an employer have the discretion to disregard a dilute result? For example, if an employer in a pre-employment test situation receives a test result that is negative and dilute, should the employer be able to require that the applicant take another test and get a negative result from an undiluted specimen before beginning to work in a safety-sensitive position? Employer Actions Section 40.159 addresses the so-called ``stand-down'' issue. Some employers have expressed a preference for standing-down employees-- taking them temporarily out of service based on a report from the MRO that the employee has a confirmed positive test, pending completion of the verification process. Some employers who have an in-house MRO appear particularly attracted to this approach. The proponents of this approach assert that it enhances safety and that it can include safeguards for employee privacy. In the program for regulated industries, the Department's current rules and interpretations have prohibited stand-down. The reason for this approach is that such policies may result in the stigmatization of employees as drug users in cases when positive laboratory results are downgraded as a result of the MRO verification process. The Department's rules have always striven to provide a balance between safety objectives and the protection of legitimate employee privacy interests. In addition, the Department is not aware of any evidence that, in the millions of tests conducted in compliance with the Department's rules since the program began in 1988, the existing prohibition on stand-downs has ever had adverse safety consequences. However, the Department's internal drug testing program for DOT employees, which applies to air traffic controllers and other safety- sensitive employees, has used a stand-down procedure for many years. Consequently, the Department's overall approach to this issue has been inconsistent. Given this situation, the Department has decided to seek comment on both approaches. The proposed regulatory text includes language, in the alternative, relating to both. Alternative 1 is the present approach, which prohibits stand-down. Alternative 2 would permit stand-down, with requirements for maintaining confidentiality of information concerning the confirmed positive test result of the employee. We seek comment on which alternative is preferable for the final rule. If the final rule permits employers to implement stand-down policies, the Department seeks comment on several associated issues. For example, should the rule specify that an employee who is stood down may continue to perform non-safety sensitive duties? What should be the pay status of an individual being stood-down? What additional privacy provisions, if any, are needed to limit dissemination of information about the employee's stand-down status based upon the existence of a laboratory positive test? Difficulties in maintaining confidentiality may be particularly acute in smaller companies (e.g., a trucking company with 10 or fewer drivers). Are there any special provisions we should include for small employers? Finally, how would a stand-down policy apply to owner-operators? It seems implausible that owner-operators would stand themselves down after being informed of laboratory positive tests by MROs. We also point out that, in addition to the proposed alternative language in Secs. 40.129 and 40.159, there may be a need for conforming changes to other sections of the regulation in the event we choose Alternative 2. We seek comment on what, if any, such additional changes to the rule would be needed. Finally, the proposed regulation would make other employer responsibilities clear. When an employer receives a report from the MRO that there is a substituted or adulterated specimen, the employer must remove the affected employee immediately from safety-sensitive functions. When the MRO informs the employer of an unsuitable specimen, the employer must direct the employee involved to immediately submit a new specimen under direct observation. Likewise, when the employer receives a report from the BAT that there is a result 0.02 or above, the employer must remove the affected employee immediately from safety- sensitive functions. Split Specimens Section 40.173 again underlines that, where split specimen testing is required by DOT regulations, employers must make sure that a test of the split occurs every time that an employee makes a timely request. Payment or agreement by the employee to pay the cost of the test is not a prerequisite for conducting a test of the split specimen, though the employer may seek to recover the cost of the test. Laboratories conducting tests of split specimens must refer a specimen to a third laboratory for additional testing when necessary (Sec. 40.177(d)). The Department also seeks comment on whether (as proposed at Sec. 40.183(d)(4)) there should be a retest under direct observation when a split specimen is unavailable for testing. Split specimen tests are statutorily mandated only in FMCSA, FTA, FRA, and FAA. They are currently optional with employers in RSPA and USCG. The Department is interested in determining if continuing use of single specimen collections by RSPA and USCG causes confusion for collectors, employers, laboratories, and MROs in light of the fact that FMCSA, FTA, FRA, and FAA are required by the Omnibus Act to use split specimen collection methodology. Will there be fewer errors in the collection process if all DOT urine specimens are collected using split specimen procedures? Will employers covered under multiple rules (e.g., RSPA and FMCSA) be less likely to order the wrong collection if all of DOT's OAs require split specimen procedures (e.g., a situation in which a pipeline repair person also drives a truck)? Is it sound policy to keep the current bifurcated specimen collection system that requires split specimen collection within some transportation [[Page 69084]] industries and permits single specimen collections for others? ``Problem'' Drug Tests The NPRM would spell out the circumstances in which an employee's actions are considered to be a refusal to test (Sec. 40.191). The NPRM also includes a list of testing problems that must or may result in cancellation of a test, including instructions on how to correct problems that would otherwise result in cancellation (Sec. 40.201). This portion of the proposed rule also notes the effect of a canceled test (Sec. 40.205) and introduces the concept of a mistake in the process which must be documented when discovered but which does not result in cancellation of the test (Sec. 40.207). We also request information on whether there are other common mistakes that we should mention in this section. In connection with the ``shy bladder'' provisions, the rule provides that a physician ``acceptable'' to the employer shall evaluate the employee (the same provision applies to inability to provide sufficient breath for an alcohol test). We understand that, in some cases, employers apparently do not check to determine the suitability of a physician to perform this evaluation. Should the language simply require the employer to ``select'' the physician? Should the rule establish criteria for this selection (e.g., expertise in urology)? The proposed rule also would incorporate 1998 DOT guidance concerning individuals whose tests are canceled on a pre-employment test because of a serious, long-term disability. These individuals could perform safety-sensitive functions after ``passing'' a physician's evaluation for signs or symptoms of drug abuse, which could include a blood test. Because pre-employment alcohol tests are no longer mandatory, is it necessary to include a similar provision in ``insufficient breath'' situations? The Department seeks comment on this question. Alcohol Test Administration Alcohol testing requirements are not proposed to be changed as much as the older drug testing requirements. Some of the changes proposed include mandatory retraining for BATs and STTs who make a mistake resulting in the cancellation of a test (Sec. 40.213(a)(3), new requirements for test site security (Sec. 40.223(a)), authorization for foreign-language testing forms (e.g., in Spanish for use in Mexico), more specific instructions on the steps for beginning alcohol tests (Sec. 40.241) and clarifications concerning the timing of confirmation tests (Sec. 40.251). There are updated sections on ``fatal flaws'' and ``correctable flaws,'' and how to correct the latter (Sec. 40.271). Section 40.233 requires quality assurance plans for evidential breath testing devices. Are these plans necessary or useful? Should the requirement be retained, changed, or eliminated? Can it be improved or modified? The Department also seeks comment on how well the current alcohol testing form is working for collection and other concerned personnel. Are there improvements we should make? We also seek comment on whether the provisions of the rule concerning the use of saliva devices (Sec. 40.245) adequately describe how these devices work, or whether we should modify this language. Substance Abuse Professionals The Department issued an Advance Notice of Proposed Rulemaking (ANPRM) in the Federal Register [June 3, 1999 (Volume 64, Number 106)] concerning the inclusion of additional groups of certified drug and alcohol addiction counselors in the definition of a SAP. The NPRM incorporates material from this ANPRM and the comments we received. An overwhelming number of respondents supported the Department's desire to streamline the process for reviewing certification groups' application materials and for evaluating the quality of those groups' certification testing processes. While some commenters favored maintaining the current review process and one favored individual certification for every SAP, the vast majority favored the Department's proposal to require National Commission for Certifying Agencies (NCCA) accreditation for certification agencies wishing to have their certified counselors included in the SAP definition. Because two counselor organizations--the National Association of Alcoholism and Drug Abuse Counselors Certification Commission (NAADAC) and the International Certification Reciprocity Consortium / Alcohol & Other Drug Abuse (ICRC)--have been through the current rigorous DOT evaluation process, the Department believes that NAADAC and ICRC will not need NCCA accreditation to have their certified counselors remain in the SAP definition. The NPRM would add training requirements for SAPs (Sec. 40.281(c)). The NPRM also clarifies the role of the employer, employee, and SAP in the return-to-duty process (Secs. 40.283 through 40.291), including a strengthened prohibition on waivers of liability. The NPRM would also incorporate into the rule text a number of existing interpretations concerning the SAP's role (e.g., a SAP assessment must be face-to-face, an employer or employee cannot ``shop around'' for a favorable SAP evaluation, no one may modify or change a SAP's assessment of an employee (Secs. 40.295 and 40.297); the SAP is to make a recommendation for a return to work agreement). The rule would also specify that recommendations for follow-up tests and post-return-to-duty follow-up treatment would be included in the SAP's recommendation, and that the employer must follow these recommendations (Secs. 40.307 and 40.309). Finally, the NPRM lists the items that must be included in SAP reports on employee evaluations (Sec. 40.311). Some SAPs have asked to receive reports of the quantity of drugs in an employee's system, to help them determine what sort of treatment might be appropriate. They do not receive quantitations in the normal course of business. Should SAPs be able to obtain this information from laboratories, much as MROs now can? The NPRM, like the current rule, requires at least six follow-up tests over the period of one year following an individual's return to safety-sensitive duties after a rule violation (e.g., positive drug test). From rehabilitation and safety viewpoints, is this minimum requirement adequate? For example, would it be better if there were a minimum requirement of twelve follow-up tests during the year? The Department seeks comment on this matter. Finally, because of the Department's growing concern that no adverse consequences exist for most applicants for DOT safety-sensitive positions who test positive on or refuse to take a pre-employment drug test, we propose to prohibit those individuals from performance of any and all DOT safety-sensitive duties until and unless the person completes the SAP evaluation, referral, and treatment process. DOT agency regulations would be modified accordingly. Confidentiality and Release of Information The basic confidentiality provision of the existing part 40 would continue in effect: Information about an employee's drug or alcohol tests can be released to third parties only with the written consent of the employee. The NPRM specifies that this consent must be specific to the information in question, not a ``blanket'' release (Sec. 40.321(b)). However, a service agent (e.g., an MRO) [[Page 69085]] can transfer their records to a successor without obtaining such consent, as long as no disclosure to outside parties occurs (Sec. 40.325(a)). MROs can, with employee consent, contact a prescribing physician to determine if an alternative medication not having side effects that adversely affect safety can be substituted (Sec. 40.327(c)). The NPRM specifies that MROs would be required to report drug test information directly, and only, to actual employers. They could not report results via an intermediary, such as a consortium or third-party administrator. Use of intermediaries has the potential to delay the transmission of results and increase the likelihood of administrative error. There is one exception to this requirement: DOT agencies could have a regulatory provision authorizing the provision of results through an intermediary. At the present time, only the Coast Guard has such a provision. No other DOT agency authorizes this practice. The proposed approach is based on the Department's 1995 guidance on the role of consortia and third-party administrators. As that guidance suggests, reporting through an intermediary might be appropriate in certain specific situations (e.g., when use of a third party is the only practicable way to direct an owner-operator to cease performing safety-sensitive functions or to report a violation to a DOT agency for purposes of taking licence or certification action following a violation). The Department is reluctant to extend these provisions any wider. What are the advantages versus the disadvantages of the current system? To resolve a dilemma that some MROs have faced, Sec. 40.329 would authorize MROs who work for more than one DOT employer to inform Employer B that an employee has had a positive test or a refusal to test in his capacity as an employee of Employer A. This proposed exception to the employee consent rule has a number of protections to ensure that it is not abused or used too broadly. Should this provision be broadened (e.g., so that the MRO could provide the information to an employer whom the MRO does not serve)? If so, how should a broadened provision be drafted in order to avoid an open-ended license to share information (e.g., within an organization with many MROs and/or a large data base)? One purpose of part 40 is to maintain an appropriate balance between safety and privacy considerations, and we seek comment on how best to strike this balance in this situation. The existing rule requires laboratories to provide certain information to employees about, among other things, their HHS certifications. Despite this requirement, laboratories have sometimes refused to provide the information. Section 40.331 specifies the scope of this requirement in greater detail and emphasizes the laboratories' obligation to comply. It should be noted that refusal by a laboratory to provide required information could subject the laboratory to public interest exclusion proceedings under subpart R. The NPRM currently authorizes the provision of information about a post-accident drug or alcohol test to the National Transportation Safety Board (NTSB), in connection with an NTSB investigation of an accident to which the post-accident test pertained. The Department seeks comment on whether this provision should be broadened to apply to other types of tests (e.g., pre-employment, random, follow-up) in the individual employee's past. Should the provision apply to the employee's urine specimens collected for the post-accident test (on which NTSB might want to conduct additional testing)? The issue involves how best to balance the potential relevance of the additional information to NTSB's investigation of the accident with the additional effects of broader dissemination of the information on the individual's privacy. If we do broaden the availability of such information to the NTSB, should the rule place conditions limiting further disclosure (e.g., in the text of NTSB reports)? Finally, in some situations a service agent may be aware that an individual is continuing to perform safety-sensitive functions despite having violated a DOT agency regulation. For example, a third-party administrator may learn that a truck driver is continuing to drive a commercial motor vehicle after having tested positive for drug use. There is no present requirement for the service agent to report such a situation to the DOT agency involved. In the interest of safety, should there be such a requirement? Service Agent Roles and Responsibilities Subpart Q of the rule is based in part on existing DOT guidance concerning the roles and responsibilities of service agents, such as third-party administrators and consortia. There is also new material, such as an explicit statement that service agents cannot impose requirements not authorized by DOT rulemaking, a reference to the subpart R public interest exclusion process and its consequences, and expanded provisions on the relationship between service agents and MROs. The Department is concerned about any potential for conflicts of interest with all service agents and welcomes comments in this area. The Department has a long-standing prohibition against the laboratory and the MRO having an affiliation or financial arrangement with one another that may be construed as a conflict of interest. Should this prohibition be strengthened? If so, how? We are also interested in your comments on what limitations, if any, should be placed upon laboratories and MROs serving as third-party administrators. How can we ensure that there exists no conflict of interest in a laboratory-based third-party administrator's selection of an MRO? Or, in an MRO-based third-party administrator's selection of a laboratory? Public Interest Exclusions (PIEs) The Department of Transportation requires hundreds of thousands of transportation employers to conduct drug and alcohol tests on millions of employees performing safety-sensitive functions. As part of this program, the Department requires the employers to comply with the specific and detailed testing procedures in part 40. These procedures ensure the accuracy, integrity, and privacy of the testing process, and they contain significant safeguards for employers and employees alike. Employers who do not comply with these procedures are subject to sanctions, such as civil penalties or withdrawal of Federal funding. Most DOT-regulated employers today do not use their own personnel to provide drug and alcohol testing services. Rather, they rely on a series of ``service agents'' (e.g., collectors, BATs, laboratories, MROs, substance abuse professionals, testing consortia, third-party administrators), with whom they contract to provide these services. When service agents fail or refuse to carry out part 40 requirements, employers who engage their services in good faith are placed at risk of being found in noncompliance and subjected to DOT sanctions. The employers--especially the many small businesses involved--do not have the expertise or resources to determine whether the service agents are providing services in a way that meets part 40 requirements. Relying on employer penalties alone to ensure service agent compliance does not adequately address the problem. For example, imposing a $1000 civil penalty on a small trucking company that has used a service agent that is not performing its functions properly does little to correct the service agent's [[Page 69086]] malfeasance. The service agent can go right on performing badly for the many other DOT employers with which it contracts. Attempting to address the problem through employer-by-employer sanctions is also a very inefficient use of the Department's resources. If a DOT agency must conduct separate civil penalty actions against 30 different employers to address the effects of a single service agent's malfeasance, its use of resources is much less efficient than if there is one DOT action focused on the service agent itself. Nor are educational efforts likely to be sufficient: existing DOT agency and private training efforts, while useful, have not prevented some recurring problems about which we know. Noncompliance by service agents with part 40 requirements can have serious consequences that go beyond the possibility of DOT sanctions on employers. For example, if an MRO is unqualified, does not conduct verification interviews, or disregards DOT rules and guidance for making verification decisions, individuals who apparently have tested positive for drugs can have their test results invalidated and be put back to work in safety-sensitive positions, endangering transportation safety, or individuals can be unfairly identified as drug users. If a collector or BAT does not conduct the collection process as part 40 provides, then valid tests can be overturned, tests will have to be repeated, and hiring actions may be delayed (in the case of pre- employment tests), creating potential safety and cost problems. If a laboratory or MRO breaches confidentiality requirements, employees' privacy rights can be compromised, upsetting the program's carefully constructed balance between the government's interest in safety and the employee's interest in privacy. To address these concerns, the Department is proposing a new subpart that would create a ``public interest exclusion'' mechanism. A public interest exclusion (PIE) would be a directive from the Department to its regulated employers to not use a service agent that fails or refuses to provide its services as part 40 requires. While a PIE obviously has adverse business consequences for the service agent involved, its imposition is not for the purpose of punishment. Its purpose is to serve the public interest by making it easier for employers to comply with our rules and to protect them from noncompliance with DOT regulations. We also believe it is important to protect employees from the consequences of services that do not meet DOT requirements. The proposed process would work as follows: When a DOT agency, ODAPC, or the Inspector General's office becomes aware of a problem with service agent performance, through an inspection or complaint, the office in question would first decide whether to pursue the matter through this process. This would be a ``prosecutorial discretion'' decision by the office, made in view of the seriousness of the problem and would, of course, be subject to the availability of DOT resources. We contemplate the use of this process only in cases having considerable significance, not for minor mistakes. In addition, in most cases, DOT offices would resort to this process only after having unsuccessfully tried other means of resolving the problem. Because the primary purpose of the process is compliance, the initiating office would first send a correction notice to the service agent, spelling out the problem and asking the service agent to fix it. If the service agent corrected its problem(s) within 60 days, no further proceedings would be necessary. If the problem(s) was not corrected, the initiating office would notify the service agent in writing that the Department was proposing to issue a PIE. To ensure that the service agent had administrative due process, it would have the opportunity to contest the issuance of a proposed PIE. This would include the opportunity to submit information and arguments in writing and to meet with the ODAPC Director in situations where there were material facts in dispute. (To ensure separation of functions, the ODAPC Director, as the decisionmaker, would not participate in the decision to initiate the proceeding, and there would be a firewall between the Director and other ODAPC, DOT agency, or IG staff concerning the case.) The Director would notify the service agent of the decision and the reasons for it in writing and issue a Federal Register notice to inform employers when a PIE was issued. The PIE would stay in effect for a period of from one to five years, depending on the seriousness of the problem. However, it could be lifted earlier if the service agent was able to show that the problem(s) resulting in the order had been corrected. This process is analogous to the procedure for imposing suspension and debarment in nonprocurement situations (see 49 CFR part 29). It should be noted that this proposed provision is not a sweeping new assertion of regulatory authority over entities who were previously untouched by DOT regulations. Provisions of both part 40 and DOT agency drug and alcohol testing regulations already govern in detail the activities conducted by laboratories, MROs, collectors, substance abuse professionals, and other service agents. The proposed provision adds no new substantive requirements. Rather, it uses the Department's existing regulatory authority over transportation employers to direct the employers, in the public interest and in the interest of their own compliance with our regulations, not to use service agents whose conduct violates part 40. The General Counsel of the Department of Transportation has determined that the Department has sufficient legal authority to implement these proposed requirements. The Department also seeks comment on three alternative methods to achieve the objective of this provision. We believe that all these alternative approaches could use due process procedures like those outlined above: (1) The process would work as described above, but instead of issuing a PIE, the Department would issue an advisory notice to employers telling them that the service agent was not providing services as required by part 40, placing employers using the agent at peril of enforcement action. (2) As a condition of participation, all service agents would be required to self-certify that they provide all services as required by Part 40. Instead of issuing a PIE, the Department would decertify service agents that failed to carry out requirements properly. (3) A contract provision in all agreements between service agents and regulated employers (see Sec. 40.11(d)) would bind service agents to providing services in compliance with Part 40. Noncompliance would breach this provision, leading to termination of the contract. The Department seeks comment on all the alternatives, combinations of them, or other means to accomplish the purpose of the proposed Subpart R, as well as on the general concept of a mechanism to protect employers and employees from noncomplying service agents. Table of Sources As noted earlier in the preamble, this proposed rule would significantly change the organization of Part 40. To help readers follow the origin of the proposed provisions, we have created a table that lists a provision of the current Part 40 or other sources of each provision. The following are examples of some of the most common types of source notations: [[Page 69087]] ``Sec. 40.33(b)''--The material in the proposed rule originated in Sec. 40.33(b) of the existing rule. This does not mean that the proposed section is the same as the existing section, but simply that the proposed section addresses the same subject matter as the existing provision. Often, the language of the proposing and exiting provisions will be different. ``Interp.''--The material in the proposed rule text comes from an interpretation issued by the Department under the present Part 40. ``9/98 guidance''--The material in the proposed rule text comes from a guidance memorandum issued by the Department in September 1998. ``Modal regulation''--The material in the proposed rule text comes from a DOT agency regulation (e.g., the FRA drug testing rule). ``New''--The material in the proposed rule would add material not found in the present Part 40 or in written interpretations or guidance. ``HHS''--The material in the proposed rule would incorporate material from the Department of Health and Human Services drug testing guidelines or HHS guidance interpreting those guidelines. ``Comment''--The material in the proposed rule responds to a comment on the ANPRM. ``Alcohol (or Drug) parallel''--The proposed rule text concerning drug testing procedures would be parallel to language on a similar provision in the alcohol testing procedures, or vice-versa. Using the table, readers should be able to readily identify the source of a given provision and where the proposed rule differs from the present Part 40. This should help commenters determine whether they support proposed changes, support existing language, or whether they wish to recommend alternatives to the proposals. In a version of the NPRM on the Department's web site, we have placed these source notes in brackets after each section, for greater convenience to the reader (Federal Register format does not permit this placement in the published version of the document). The table follows: ------------------------------------------------------------------------ Section of NPRM Source ------------------------------------------------------------------------ 40.1............................... 40.1 40.3............................... 40.3, HHS, except ``alcohol test,'' ``designated employer representative,'' ``dilute specimen,'' ``notice,'' ``service agents,'' and ``substituted specimen,'' which are new. 40.5............................... New 40.7............................... 49 CFR part 5, interp. 40.11.............................. New 40.13(a)........................... New (b).......................... Comment 40.15 (a), (b), (d), (e), (f)...... Interp. (c).......................... 40.21(c) 40.17(a)........................... Guidance (b), (c)..................... New 40.19.............................. Interp. 40.21.............................. New 40.31 (a), (b)..................... New (c).......................... 40.23(d)(3), interp. (d).......................... 40.23(d)(3) 40.33 (a)(1)....................... New (a)(2)(i).................... 40.23(d)(2) (a)(2)(iii).................. 40.23(d)(1) (a)(3)-(5)................... New (b).......................... New 40.35.............................. New 40.37.............................. New 40.41 (a), (b)..................... New (c).......................... 40.25(a)(1) (d)(1), (3).................. 40.25(a)(2) (d)(2)....................... New (e).......................... 40.25(a)(2), HHS (f), (g)..................... 40.25(a)(1) 40.43(a)........................... 40.25(b) (b)(1)-(6)................... 40.25(b)(1)-(2) (b)(7)-(8)................... New (c).......................... 40.25(b)(2) (d)(1)....................... 40.25(d) (d)(2)....................... 40.25(g) (d)(3)....................... 40.25(d) (d)(4)....................... 40.25(f)(25)(ii) (d)(5)....................... 40.25(f)(25)(i) (e).......................... 40.25(d) (e)(1)-(4)................... New 40.45(a)........................... 40.23(a)(1)(i) (b)(1)....................... 40.23(a)(1)(ii) (b)(2)-(5)................... Comments (c).......................... 40.23(a)(1)(ii) (d).......................... 40.23(a)(1)(iii) (e).......................... New 40.47(a)........................... Interp. (b).......................... Interp., new 40.49.............................. New 40.51.............................. Interp., new [[Page 69088]] 40.61(a)........................... 40.25(f)(3), new (b).......................... Interp. (b)(1)....................... New (b)(2)....................... 40.25(j) (b)(3)....................... Interp. (c).......................... 40.25(f)(2), HHS (d).......................... 40.25(f)(2), new (e).......................... Alcohol parallel (f)(1)-(2)................... 40.25(f)(4) (f)(3)....................... Interp., HHS (f)(4)-(6)................... New (g).......................... 40.25(f)(22)(ii) 40.63 (a).......................... Alcohol parallel (b).......................... 40.25(f)(5)-(6), (11) (c).......................... 40.25(f)(7), HHS, interp. (d).......................... 40.25(f)(10), new (e).......................... 40.25(f)(8), new 40.65.............................. Checklist format new (a).......................... New, interp. (b) (1)-(5).................. 40.25(e)(2) (b)(6)....................... Interp. (b)(7)....................... Interp., new (c).......................... New, interp. 40.67(a)(1)........................ HHS (a)(2)....................... New (b)(1)....................... 40.25(e)(2)(iv) (b)(2)....................... 9/98 guidance (c)(1)....................... New (c)(2)....................... 40.25(e)(2)(iii); new (c)(3)....................... 40.25(e)(2)(i) (c)(4)....................... 40.25(e)(2)(iii) (d).......................... HHS (e).......................... New (f).......................... 40.25(f)(16), interp., HHS (g).......................... New (h).......................... Interp. (i).......................... Interp., HHS (j).......................... HHS (k).......................... Interp. 40.69(a)........................... 40.25(f)(9) (b)-(c)...................... New (d)-(h)...................... 40.25(f)(9), Interp. (i).......................... HHS (j).......................... Interp. 40.71(a)........................... 40.25(f)(10)(iii) (b).......................... New (c).......................... 40.25(f)(19), HHS (d).......................... 40.25(f)(10)(iii), 40.25(f)(17) (e).......................... 40.25(f)(20) (f).......................... New 40.73 (a)-(b)...................... 40.25(f)(19)(ii)(B)(1), new (c).......................... New (d).......................... 40.25(f)(19), HHS (e).......................... 40.25(f)(10)(iii), 40.25(f)(17) (f).......................... 40.25(f)(20) 40.75(a)(1)........................ 40.25(f)(22)(i), HHS (a)(2)....................... 40.25(f)(23), HHS (a)(3)-(4)................... HHS (a)(5)....................... New (a)(6)-(7)................... HHS (a)(8)-(10).................. New (a)(11)...................... HHS (b).......................... 40.25(c), (h), (k) (c).......................... New 40.81(a)........................... 40.39(a) (b).......................... 40.39(b) (c)-(d)...................... New 40.83(a)-(c)....................... 40.25(k), 40.29(a)(2) (d).......................... HHS, new (e).......................... Interp. (f).......................... Interp., new (g).......................... New 40.85.............................. 40.21(a) 40.87(a)........................... 40.29(e)(1), new [[Page 69089]] (b).......................... 40.29(f) 40.89(a)........................... 40.29(e)(1) and (f)(1) (b)-(c)...................... 40.29(g)(2) 40.91 (a)-(b)...................... New, HHS (c).......................... 9/98 guidance (d).......................... HHS 40.93.............................. New, HHS 40.95(a)........................... 40.29(g)(1) (b)-(e)...................... HHS, new 40.97(a)........................... 40.29(g)(4), new (b)(1)....................... HHS, new (b)(2)....................... 40.29(g)(4), new (c).......................... 40.29(g)(4) (d)-(e)...................... New 40.99(a)(1)........................ 40.29(b)(2), HHS (a)(2)....................... 40.29(h), HHS (b).......................... 40.29(h) (c)-(e)...................... New 40.101(a).......................... 40.29(n)(6), new (b).......................... New 40.103(a).......................... 40.31(d)(1)-(2), new (b).......................... 40.31(d)(5), new (c).......................... 40.31(d)(3) (c)(1)....................... HHS (c)(2)....................... New (d).......................... HHS, new 40.105(a).......................... 40.31(d)(7)-(8), new (b).......................... 40.31(d)(8) (c).......................... 40.31(d)(7), new (d).......................... 40.31(d)(8), new 40.107............................. 40.29(1) 40.109(a)-(b)...................... New (c).......................... 40.29(g)(6), 40.29(m) (d).......................... 40.29(m), new (e).......................... HHS, new 40.111............................. 40.29(g)(6), HHS, new 40.113............................. New 40.121(a).......................... 40.33(b)(1) (b).......................... 40.33(a) (c)-(f)...................... New 40.123............................. New 40.125............................. 40.33(b)(2), new 40.127(a).......................... 40.33(a)(2), new (b).......................... Interp., new (c)-(d)...................... New (e).......................... 9/98 guidance, new 40.129(a)(1)....................... 40.33(a), interp. (a)(2)....................... New (a)(3)....................... 40.33(c)(1)-(2) (a)(4)....................... 40.33(a)(2) (a)(5)....................... New (b).......................... Interp., new (c).......................... 9/98 guidance (d).......................... Interp., new 40.131(a)-(c)...................... 40.33(c)(2), new (d).......................... 40.33(c)(3)-(4), new 40.133(a).......................... 40.33(c)(3), (c)(5) (b).......................... New (c).......................... 40.33(c)(6) 40.135 (a)-(c)..................... New (d).......................... 40.33(i)(2) 40.137(a)-(b)...................... 40.33(a), (b)(3), (c) (c)-(d)...................... Interp. 40.139(a).......................... 40.33(d) (b).......................... New (c).......................... 40.33(d), new (c)(1)-(4)................... Interp., new, MRO training materials 40.141............................. New (a).......................... 40.33(a), (b)(3), new (b).......................... 40.33(b)(3), new (c).......................... 40.33(e) 40.143(a).......................... 40.33(b)(3), interp. (b).......................... New (c).......................... Interp. [[Page 69090]] (d).......................... Interp., MRO training materials (e).......................... Interp. (f).......................... Guidance 40.145(a).......................... New (b).......................... 40.33(e)-(f) (c).......................... New (d).......................... New, interp. (e).......................... 40.33(e)-(f) (f).......................... Interp. 40.147(a)-(b)...................... 9/98 guidance, new (c).......................... Interp., new 40.149(a)-(b)...................... 9/98 guidance, new (c).......................... Interp., new 40.151(a).......................... 9/98 guidance (b)-(c)...................... Interp., new 40.153(a).......................... 9/98 guidance, new (b).......................... Interp., new 40.155............................. New 40.157 (a)-(b)..................... Alcohol parallel--40.65(i) (c).......................... FMCSA regulation--49 CFR 382.407(a)(1) (d).......................... New 40.159(a).......................... 40.33(a)(1),interp., new (b).......................... New (c)-(f)...................... 9/98 guidance, new (g).......................... New 40.161(a).......................... Interp. (b).......................... New 40.163............................. New 40.171(a).......................... 40.33(f) (b).......................... 40.33(g) (c).......................... Interp. (d).......................... 40.25(f)(10)(E) 40.173............................. Interp. 40.175(a).......................... 40.129(b)(2), new (b).......................... New (c).......................... 40.29(c) (c)(1)-(2)................... 40.29(b)(2), new (d).......................... 40.25(f)(10)(F) (e).......................... 40.33(f) (f).......................... Interp. (g).......................... New 40.177(a).......................... HHS (b).......................... 40.29 (b)(3) (c)-(d)...................... HHS (e).......................... Interp. 40.179............................. New 40.181............................. HHS 40.183............................. 9/98 guidance, new 40.185............................. New 40.187............................. New 40.191(a)(1)....................... Interp., comment (a)(2)....................... Modal regulations (a)(3)....................... Interp. (a)(4)....................... 40.25(f)(10)(iv)(2), 40.69(d)(2)(ii) (a)(5)-(6)................... Interp. (a)(7)....................... 40.67(a) (b).......................... 9/98 guidance (c).......................... Modal regulations (d).......................... 40.67(a), interp. (e).......................... Comment 40.193 (a)-(f), (h)-(i)............ 40.25(f)(10)(iv) (g).......................... Guidance, new 40.195............................. Guidance, new 40.197............................. DOT and HHS guidance, interp. 40.199............................. Guidance, new 40.201............................. DOT and HHS guidance, interp., new 40.203(a).......................... 40.67(b), new (b).......................... New, interp. 40.205............................. Interp. 40.207............................. Interp., new 40.211(a)-(c)...................... 40.51, 40.93 (d).......................... 40.51(b), new 40.213(a)(1)....................... 40.51(a)(1) (a)(1)(i).................... 40.51(a)(2) [[Page 69091]] (a)(1)(ii)................... 40.51(a)(3) (a)(1)(iii).................. Interp. (a)(1)(iv)................... Drug parallel (a)(2)....................... 40.93(c) (a)(3)....................... New (b)(1)....................... 40.51(a)(1) (b)(1)(i).................... 40.51(a)(2) (b)(1)(ii)................... 40.51(a)(3) (b)(1)(iii).................. New (b)(1)(iv)................... Drug parallel (b)(3)....................... New (c).......................... Interp. (d).......................... 40.51(c) (e)-(g)...................... New 40.215............................. New 40.217............................. New 40.221(a)-(b)...................... New (c)-(d)...................... 40.57(a) (e).......................... 40.57(e) (f).......................... 40.57(b) 40.223(a).......................... 40.57, new (b).......................... 40.55(c) (c).......................... 40.57(c) (d).......................... 40.57(e), 40.99(b) (d)(1)....................... New (d)(2)....................... Interp. (d)(3)....................... 40.57(e), 40.99(b) 40.225(a).......................... 40.59(a) (b)(1)....................... Drug parallel-40.23(a)(1)(i) and CCF (b)(2)....................... 40.59(a) (b)(3)-(6)................... Comment (c).......................... New 40.227(a).......................... Interp. (b).......................... New 40.229............................. 40.53, 40.91 40.231(a).......................... 40.53(a), 40.91 (b).......................... 40.53(b) 40.233(a).......................... 40.55(a) (a)(1)....................... 40.55(a)(1)-(3) (a)(2)....................... 40.55(a)(4) (b).......................... 40.55(b), (b)(1), new (c).......................... 40.55(a)(1) (d).......................... 40.55(b)(2) (e).......................... 40.55(b)(4) (f).......................... 40.55(b)(3) 40.235(a).......................... 40.95 (a), (a)(1) (b).......................... 40.95(b), (c) (c).......................... New (d).......................... 40.55(a)(2) 40.241(a).......................... New (b)(1)....................... New, Drug parallel--40.25(f)(3) (b)(2), (b)(2)(i)............ New (b)(2)(ii)................... Drug parallel--40.25(j) (b)(3)....................... Drug parallel--40.25(f)(2) (b)(4)....................... Drug parallel--40.25((f)(2), new (b)(5)....................... 40.61(b), 40.101(d)(1) (b)(6)-(7)................... 40.63(a), 40.101(b) 40.243(a).......................... Drug parallel--40.25(f)(7), HHS, interp. (b).......................... 40.63(b) (c).......................... 40.63(c) (d).......................... 40.63(d)(2)(i), (d)(3), (d)(4) (e).......................... New (f).......................... 40.63(d)(3) (g).......................... 40.63(d)(2)(i) 40.245(a).......................... 40.101(d)(2) (b).......................... 40.101(d)(3) (c).......................... New (d).......................... 40.101(d)(5) (e).......................... 40.101(d)(6) (f).......................... 40.101(d)(7) (g).......................... 40.101(d)(8) (h).......................... 40.101(d)(9) (i).......................... 40.101(d)(10) 40.247(a).......................... 40.101(e) [[Page 69092]] (b)(1)....................... 40.63(e)(1), 40.101(e) (b)(2)....................... 40.62(e)(i)(3) (b)(3)....................... 40.63(e)(2) (c)(1)....................... 40.63(f) (c)(2)....................... 40.63(g), 40.101(e) (c)(3)(i)-(iv)............... 40.63(h)(1) (c)(3)(v)-(vii).............. 40.63(h)(2) (c)(3)(viii)................. New (c)(3)(ix)................... 40.63(h)(3) (d).......................... 40.63(e)(4) 40.251(a)-(b)...................... 40.65(b), new (c).......................... 40.63(a), 40.101(b) (d).......................... 40.65(b), new 40.253(a).......................... 40.65(d) (b).......................... 40.63(b), 40.65(c)(2) (c).......................... 40.65(e) (d).......................... 40.63(b), 40.65(c)(2) (e)-(f)...................... 40.65(g)(1)-(2) (g).......................... 40.65(g)(1) 40.255(a)(1)....................... 40.65(h)(1) (a)(2)....................... 40.65(h)(1)-(2) (a)(3)....................... 40.65(h)(3) (a)(4)....................... 40.65(i)(1) (a)(4)(i).................... 40.65(i)(1)-(2) (a)(4)(ii)................... 40.65(i)(4) (b)(1)....................... 40.65(i)(3) (b)(2)....................... 40.65(i)(4) 40.257............................. New, drug parallel 40.261(a)(1)....................... Interp., comment (a)(2)....................... Modal regulations (a)(3)....................... 40.63(e)(3) (a)(4)....................... 40.69(d)(2)(ii), drug parallel- 40.25(f)(10)(iv)(2) (a)(5)....................... Interp. (a)(6)....................... 40.67(a), interp. (b).......................... Modal regulations (c).......................... 40.67(a), interp. 40.263............................. 40.105 40.265............................. 40.69, 40.105 40.267(a)(1)....................... 40.107(a)(1) (a)(2)....................... 40.107(a)(2) (a)(3)....................... 40.107(a)(3) (b).......................... 40.79(a)(7), 40.107(b) (c)(1)....................... 40.79(a)(2) (c)(2)-(3)................... 40.79(a)(3) (c)(4)....................... 40.79(a)(6) (c)(5)....................... 40.79(a)(1) 40.269(a).......................... 40.79(a)(4) (b).......................... 40.79(a)(5), 40.107(b) (c).......................... 40.107(a)(4) (d).......................... New 40.271(a).......................... 40.67(b), new (b).......................... New, interp. 40.273............................. Interp. 40.275............................. New, interp. 40.277............................. Interp. 40.281............................. Interp., new, 40.3 40.283............................. Modal regulations, new 40.285............................. Modal regulations, new 40.287(a).......................... Modal regulations, interp. (b).......................... Modal regulations, new (c)-(e)...................... Interp. 40.289............................. Modal regulations, SAP guidelines 40.291............................. Interp. 40.293............................. Interp., SAP guidelines, modal regulations 40.295............................. Interp. 40.297............................. Interp., SAP guidelines 40.299(a).......................... SAP guidelines (b).......................... SAP guidelines, modal regulations (c).......................... Modal regulations, examples new (d).......................... New 40.301............................. Interp., SAP guidelines, modal regulations 40.303............................. New 40.305............................. Interp., SAP guidelines 40.307............................. Modal regulations, interp., SAP guidelines [[Page 69093]] 40.309............................. Modal regulations, interp., SAP guidelines 40.311 all except.................. Interp., SAP guidelines (e)(10), (f)................. New 40.313............................. New 40.321............................. 40.3(i), 40.35, 40.81(b), (g), (i) (a).......................... New (b).......................... Interp. 40.323............................. 40.35, 40.81(H) 40.325............................. New 40.327 (a)......................... 40.33(i)(1)--(2), new (b).......................... 40.33(i)(1)(ii)--(iii) (c).......................... New 40.329............................. New 40.331(a).......................... 40.37, 40.81(c) (b)--(c)..................... Interp. 40.333 (a)......................... 40.81(g), (i) (b)(1)....................... 40.81(d) (b)(2)....................... 40.81(e), new (c)(1)....................... 40.81(d) (c)(2)....................... 40.81(e), new (d).......................... 40.81(f) (e).......................... New 40.335............................. 40.81, 382.401 40.341--40.353..................... Consortium/third party administrator guidance 40.361--40.385..................... New ------------------------------------------------------------------------ Regulatory Analyses and Notices This rule is a significant rule for purposes of Executive Order 12866. It is significant because of its policy importance and its impact upon sizeable industries. It is not, however, an economically significant regulation. It is a reworking of existing requirements, imposing few new mandates, and should not have significant incremental costs. Because of its multimodal impact and policy interest to regulated parties and service agents, it is a significant rule for purposes of the DOT Regulatory Policies and Procedures. Throughout this regulation, we have attempted to balance the costs of new requirements with the cost savings accrued through the elimination of some current requirements. There are two features of the proposed regulation that would add new requirements that may have some economic impacts. The first is the requirement that laboratories test for dilute, substituted, and adulterated specimens. Existing regulations were devised before the widespread use of ``designer'' adulterants that some employees are putting into their urine to mask the results of positive drug tests. The DOT has worked with HHS and laboratory scientists to develop a set of appropriate forensic testing protocols for identifying these masking agents. The revision expands existing regulations and guidance concerning these difficult testing situations by making mandatory laboratories' use of additional protocols for discovering adulteration, as well as for detecting situations in which an employee has substituted something other than normal human urine for the required urine specimen. As the result of work by HHS and the laboratories, these protocols are already in place and are being used by most laboratories, so we expect the incremental costs of this requirement to be modest. The Department believes that public safety is well-served by these steps to identify and hold accountable employees in safety-sensitive positions who attempt to cheat the testing process. Second, the Department is proposing additional training requirements for some service agents. Errors in the testing process resulting from lack of training can lead to increased employer program costs and increased paperwork required to document the errors and repeat the testing process. The NPRM would upgrade requirements for urine collectors and other personnel. This additional training requirement can be met without formalized instruction to minimize the cost impact. Also, MROs and SAPs would either attend a training session every two years to keep current on developments in the field or would be permitted to self-certify they have re-reviewed and understand the regulations in lieu of training. These training courses already exist and are widely attended. Again, we anticipate that overall net costs of these new training requirements and options would be quite modest because the requirement may be met without formalized instruction. At the same time, the Department anticipates cost savings from some provisions of the regulation, such as the reductions in blind specimen requirements and mitigation of some reporting requirements. The additional training requirements discussed in the previous paragraphs will help to reduce costs from errors in the system. For example, every time a better-trained collector conducts a collection properly instead of making a mistake, the costs of developing memorandums for correction, preparing laboratory litigation packages, arbitration or court proceedings, and reversing personnel actions are avoided. The Department has made some preliminary estimates of the cost increases and decreases that could be expected if the proposed rule's provisions are made final. It is important to understand that this is a big program, touching some 8.34 million employees working for about 673,413 employers. Around 30,000 individuals and organizations work as service agents. In terms of new costs, the Department estimates an annual cost of about $902,000 for adulterant testing plus about $25,322 for training documentation. We believe there will not be any measurable additional costs for actual SAP and MRO training, because most SAPs and MROs already undergo such training as part of professional continuing education requirements. The option also exists for MROs and SAPs to self-administer training through study of DOT rules and guidance. In addition, we estimate that there will be one-time costs for a variety [[Page 69094]] of administrative requirements in the first year of implementation of approximately $1.93 million. On the other hand, we anticipate saving at least $5.4 million annually from the proposed reduction in blind specimen testing (the savings will probably be somewhat greater, because fewer organizations will be required to submit blind specimens). By changing the current quarterly laboratory report requirement to require a semiannual report, we anticipate saving another $1.69 million annually. By permitting positive test results to be faxed rather than sent by overnight express, we project an annual $3.1 million saving. These annual savings are greater than the additional annual costs we anticipate for the proposed rule. This NPRM does not have sufficient Federalism impacts to warrant a Federalism assessment under Executive Order 13132. With respect to the Regulatory Flexibility Act, the Department certifies that, if adopted, this rule would not have a significant economic impact on a substantial number of small entities, so a Regulatory Flexibility analysis has not been prepared. While this rule affects a large number of small entities, we do not expect the rule to have a significant economic impact on anyone. This rulemaking involves a ``610 Review'' under the Small Business Regulatory Enforcement Fairness Act. We have reviewed the existing program to identify areas in which the rule can be improved with the effect of assisting small businesses to comply in a rational and cost- effective manner. In addition to the general clarification of the program this rule provides, we have identified some specific areas (e.g., blind specimen requirements, the addition of the public interest exclusion provision) that should be particularly helpful to small regulated employers. We seek comment on any changes that commenters might suggest to further assist small businesses who are affected by this rule. Part 40 is one portion of a ``ONE-DOT'' drug and alcohol testing program that also involves regulations from six DOT agencies. The costs and impacts of Part 40 are intertwined with the costs and impacts of the DOT agency regulations. In connection with the 610 review, we are seeking comments on the effects of the entire program, including all its regulatory components, on small entities and on ways of improving the program from this point of view. This proposed rule also contains information collection requirements. As required by the Paperwork Reduction Act of 1995 (the PRA, 44 U.S.C. 3507(d)), the Department has submitted these requirements to the Office of Information and Regulatory Affairs of the Office of Management and Budget for review, as required under the Paperwork Reduction Act. As noted elsewhere in this preamble, this proposed rule would amend 49 CFR Part 40 to clarify and update the Department's alcohol and drug testing procedures. In the course of so doing, the proposal would increase some information collection requirements and decrease others, resulting in what we estimate to be a modest net reduction in information collection burdens, compared to the present regulation. The information collections involve such subjects as drug and alcohol specimen collection, quality control, and the reporting and retention of drug and alcohol testing information. The regulated parties to whom these requirements apply are transportation employers and participants in the drug and alcohol testing industry, the numbers of which are summarized above. As summarized above, the Department anticipates that there will be new costs of $2.86 million and new savings of about $10.9 million, most of which represent costs involved with information collection. In terms of burden hours, we anticipate new collections amounting to 65,000 hours and savings on collections amounting to 168,888 hours, resulting in a net reduction of 103,888 hours compared to the present regulation. The Department is soliciting comments to (1) evaluate whether the proposed collections are necessary for the functioning of the drug and alcohol testing program, including whether the information will have practical utility; (2) evaluate the accuracy of the Department's estimate of the burden; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of information collection for regulated parties, including through the use of appropriate automated, electronic, mechanical, or other technological information collection techniques or other forms of information technology (for example, permitting electronic submission of reports). Individuals and organizations may submit comments on the information collection elements of this NPRM by April 7, 2000 and should direct them to the DOT docket specified at the beginning of the NPRM. According to OMB's regulations implementing the PRA (5 CFR 1320.8(b)(2)(vi)), an agency may not conduct or sponsor, and a person need not respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information will be published in the Federal Register after it is approved by OMB. There are a number of other Executive Orders that can affect rulemakings. These include Executive Orders 13084 (Consultation and Coordination with Indian Tribal Governments), 12988 (Civil Justice Reform), 12875 (Enhancing the Intergovernmental Partnership), 12630 (Governmental Actions and Interference with Constitutionally Protected Property Rights), 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations), 13045 (Protection of Children from Environmental Health Risks and Safety Risks), and 12889 (Implementation of North American Free Trade Agreement). We have considered these Executive Orders in the context of this NPRM, and we believe that the proposed rule does not directly affect the matters that the Executive Orders cover. We have prepared this rulemaking in accordance with the Presidential Directive on Plain Language. List of Subjects in 49 CFR Part 40 Administrative practice and procedure, Alcohol abuse, Alcohol testing, Drug testing, Laboratories, Reporting and recordkeeping requirements, Safety, Transportation. Issued this 29th day of November, 1999, at Washington, DC. Rodney E. Slater, Secretary of Transportation. For the reasons set forth in the preamble, the Department of Transportation proposes to revise part 40 of Title 49, Code of Federal Regulations, to read as follows: PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS Subpart A--Administrative Provisions Sec. 40.1 Whom does this regulation cover? 40.3 What do the terms used in this regulation mean? 40.5 Who issues authoritative interpretations of this regulation? 40.7 How are exemptions granted from this regulation? Subpart B--Participant Responsibilities 40.11 What are the basic responsibilities of employers under this regulation? 40.13 If an employer has employees subject to testing under both DOT and the Nuclear Regulatory Commission (NRC) regulations, what procedures does it follow? [[Page 69095]] 40.15 If an employer conducts non-DOT testing, under its own authority, as well as DOT testing, what Federal restrictions apply for the two tests? 40.17 Can an employer use a service agent to meet DOT drug and alcohol testing requirements? 40.19 May service agents impose requirements on employers that DOT agency regulations do not specifically authorize? 40.21 Do service agents have to comply with DOT drug and alcohol testing requirements? Subpart C--Urine Collection Personnel 40.31 Who collects urine specimens for DOT drug testing? 40.33 What requirements must a collector meet? 40.35 What requirements must organizations employing collectors meet? 40.37 Where is other information on the role of collectors found in this regulation? Subpart D--Collection Sites, Forms, Equipment and Supplies Used in DOT Urine Collections 40.41 Where does a urine collection for a DOT drug test take place? 40.43 What steps must collection sites take to protect the security and integrity of urine collections? 40.45 What form is used to document a DOT urine collection? 40.47 May employers use the CCF for non-DOT collections or non- Federal forms for DOT collections? 40.49 What materials are used to collect urine drug specimens? 40.51 What materials are used to send urine specimens to the laboratory? Subpart E--Drug Test Collections 40.61 What are the preliminary steps in the collection process? 40.63 What steps does the collector take in the collection process before the employee provides a urine specimen? 40.65 What does the collector check for when the employee presents a specimen? 40.67 When and how is a directly observed collection conducted? 40.69 When and how is a monitored collection conducted? 40.71 How does the collector process a single specimen collection? 40.73 How does the collector process a split specimen collection? 40.75 How is the collection process completed? Subpart F--Drug Testing Laboratories 40.81 What laboratories may be used for DOT drug testing? 40.83 How do laboratories process incoming specimens? 40.85 What drugs do laboratories test for? 40.87 What methods do laboratories use for screening and confirmation tests? 40.89 What are the cutoff concentrations for screening and confirmation tests? 40.91 What additional testing must be done by laboratories on primary specimens? 40.93 What methods and criteria do laboratories use for validity testing? 40.95 What do laboratories need to report to MROs regarding primary specimen results? 40.97 Through what methods and to whom must a laboratory transmit results? 40.99 How long does the laboratory retain specimens after testing? 40.101 What relationship may a laboratory have with an MRO? 40.103 What blind specimens must be sent to a laboratory? 40.105 What happens if there is a laboratory error on any test? 40.107 Who may inspect laboratories? 40.109 What documentation must the laboratory keep, and for how long? 40.111 When and how must a laboratory disclose statistical summaries and other information it maintains? 40.113 Where is other information concerning laboratories found in this regulation? Subpart G--Medical Review Officers (MROs) 40.121 Who is qualified to act as an MRO? 40.123 What are the MRO's responsibilities in the DOT drug testing program? 40.125 What relationship may an MRO have with a laboratory? 40.127 What are the MRO's functions in reviewing negative test results? 40.129 What are the MRO's functions in reviewing laboratory confirmed positive drug test results? 40.131 How is the employee notified of the verification process after a confirmed positive test result? 40.133 Under what circumstances may the MRO verify a test as positive without interviewing the employee? 40.135 What does the MRO tell the employee at the beginning of the verification interview? 40.137 On what basis does the MRO verify test results involving marijuana, cocaine, amphetamines, and PCP? 40.139 On what basis does the MRO verify test results involving opiates? 40.141 How does the MRO obtain information for the verification decision? 40.143 What are MROs prohibited from doing as part of the verification process? 40.145 How does the MRO notify employees of their right to a test of the split specimen or to a retest of a single specimen? 40.147 What happens when a negative or positive test result is also dilute? 40.149 What happens when a test is not performed because of a fatal or uncorrected flaw? 40.151 What happens when a drug test specimen is unsuitable for testing? 40.153 What happens when a drug test specimen is substituted or adulterated? 40.155 What happens when a drug test specimen is rejected for testing? 40.157 How does the MRO report test results to the employer? 40.159 When MROs send reports of positive, dilute, unsuitable, substituted, or adulterated test results to employers, what is an employer to do? 40.161 May the employer or MRO change a verified drug test result? 40.163 Where is other information concerning the role of MROs found in this regulation? Subpart H--Split Specimen Tests and Retests 40.171 How does an employee request a test of a split specimen? 40.173 Who is responsible for paying for the test of a split specimen? 40.175 What steps does the first laboratory take with a split specimen? 40.177 What does the second laboratory do with the split specimen? 40.179 Through what methods and to whom must a laboratory transmit split specimen results? 40.181 What information do laboratories need to report to MROs regarding split specimen results? 40.183 What does the MRO do with the split specimen laboratory results? 40.185 Are employees' requests for reanalysis of the specimen from a single specimen collection handled the same way as requests for the test of the split specimen? 40.187 Where is other information concerning split specimens found in this regulation? Subpart I--Problems in Drug Tests 40.191 What is a refusal to take a DOT drug test, and what are the consequences? 40.193 What happens when an employee is unable to provide a sufficient amount of urine for a drug test? 40.195 What happens when an individual is unable to provide a sufficient amount of urine for a pre-employment drug test because of a permanent or long-term disability? 40.197 What problems will always result in a drug test being canceled? 40.199 What problems will always result in a drug test being canceled and may result in a requirement for another collection? 40.201 What problems will result in the drug test being canceled unless they are corrected? 40.203 How are drug test problems corrected? 40.205 What is the effect of a canceled drug test? 40.207 What is the effect of procedural problems that are not sufficient to cancel a drug test? Subpart J--Alcohol Testing Personnel 40.211 Who conducts DOT alcohol tests? 40.213 What requirements must STTs and BATs meet? 40.215 What requirements must organizations employing STTs and/or BATs meet? 40.217 Where is other information on the role of STTs and BATs found in this regulation? Subpart K--Testing Sites, Forms, Equipment and Supplies Used In Alcohol Testing 40.221 Where does an alcohol test take place? [[Page 69096]] 40.223 What steps must be taken to protect the security of alcohol testing sites? 40.225 What form is used for an alcohol test? 40.227 May employers use the BATF for non-DOT tests, and vice- versa? 40.229 What devices are used to conduct alcohol screening tests? 40.231 What devices are used to conduct alcohol confirmation tests? 40.233 What are the requirements for proper use and care of EBTs? 40.235 What are the requirements for proper use and care of ASDs? Subpart L--Alcohol Screening Tests 40.241 What are the first steps in any alcohol screening test? 40.243 What is the procedure for an alcohol screening test using an EBT or non-evidential breath ASD? 40.245 What is the procedure for an alcohol screening test using a saliva ASD? 40.247 What happens next after the alcohol screening test result? Subpart M--Alcohol Confirmation Tests 40.251 What are the first steps