{"operation":"document","citation":"65 FR 79462","title":"Procedures for Transportation Workplace Drug and Alcohol Testing Programs","source_type":"rulemaking","agency":"Office of the Secretary","status":"historical","official":true,"published_on":"2000-12-19","effective_on":"2001-01-18","summary":"The Department of Transportation is revising 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.","machine_formats":{"json":"https://regulus.evalyn.ai/document/federal-register-00-31251.json","markdown":"https://regulus.evalyn.ai/document/federal-register-00-31251.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-00-31251","source_url":"https://www.federalregister.gov/documents/2000/12/19/00-31251/procedures-for-transportation-workplace-drug-and-alcohol-testing-programs","body":"Federal Register, Volume 65 Issue 244 (Tuesday, December 19, 2000) [Federal Register Volume 65, Number 244 (Tuesday, December 19, 2000)] [Rules and Regulations] [Pages 79462-79579] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 00-31251] [[Page 79461]] ----------------------------------------------------------------------- Part II Department of Transportation ----------------------------------------------------------------------- Office of the Secretary ----------------------------------------------------------------------- 49 CFR Part 40 Procedures for Transportation Workplace Drug and Alcohol Testing Programs; Final Rule Federal Register / Vol. 65 , No. 244 / Tuesday, December 19, 2000 / Rules and Regulations [[Page 79462]] ----------------------------------------------------------------------- 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: Final rule. ----------------------------------------------------------------------- SUMMARY: The Department of Transportation is revising 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. EFFECTIVE DATES: The amendments to the current 49 CFR part 40 are effective January 18, 2001. The revised 49 CFR Part 40 is effective August 1, 2001. FOR FURTHER INFORMATION CONTACT: Robert C. Ashby, Deputy Assistant General Counsel for Regulation and Enforcement, 400 7th Street, SW., Room 10424, Washington DC, 20590, 202-366-9310 (voice), 202-366-9313 (fax), or [email protected] (e-mail); Mary Bernstein, Director, Office of Drug and Alcohol Policy and Compliance (ODAPC), 400 7th Street, SW., Room 10403, Washington DC, 20590, 202-366-3784 (voice), 202-366-3897 (fax), or [email protected] (e-mail); or Jim L. Swart, Drug and Alcohol Policy Advisor, ODAPC , same address and phone numbers as above, [email protected] (e-mail). SUPPLEMENTARY INFORMATION: Background The Department of Transportation first published its drug testing procedures regulation (49 CFR part 40) on November 21, 1988 (53 FR 47002), as an interim final rule. We based the rule on the Department of Health and Human Services (HHS) guidelines for Federal agency employee drug testing, with some changes to fit the transportation workplace. 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 1994 final rule. This rule also made other changes to Part 40, including requirements for split samples in four operating administration rules. 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 and ``shy bladder'' procedures). In the years since Part 40 was first published, the Department 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 previously been incorporated into the rule 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 that make it desirable to update our regulatory provisions. Because the rule was originally based on that of another agency (i.e., HHS), 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. We then issued a notice of proposed rulemaking (NPRM) on December 9, 1999 (64 FR 69076). This NPRM proposed a comprehensive revision to Part 40. In response to the NPRM, we received letters from over 400 commenters, making around 4000 individual suggestions concerning the rule. We also held three public listening sessions, at which numerous interested parties commented further on the Department's proposals, and we held an internet forum. The final rule responds to all the comments and makes significant alterations to the existing rules governing the Department's drug and alcohol testing programs. Structure of the Rule Perhaps the first thing readers will notice about this final rule is that we have thoroughly restructured Part 40, with subparts organized by subject matter area. Like the NPRM, and in contrast to the existing rule, the text is divided into many more sections, with fewer paragraphs each on average, to make it easier to find regulatory provisions. The rule uses a question-answer format, with language specifically directing particular parties to take particular actions (e.g., ``As an employer, you must * * *''). We have also tried to express the requirements of the rule in plain language. Commenters were very complimentary about the reorganization of the rule, generally praising it as much clearer and easier to follow than the existing rule. The Department received a plain language award, known as the ``No Gobbledygook Award,'' from Vice President Gore's National Partnership for Reinventing Government in recognition of the improved clarity of the regulation. We have retained the NPRM's format and organization, which we believe will help drug and alcohol testing program participants understand and effectively carry out this rule. What matters most in a rulemaking is not the number of letters favoring or opposing a particular proposal. Our central concern is with the substance of the comments. In discussing comments on this rule and our response to them, we will focus on the substance of positions that commenters expressed, and on why we did or did not make changes in response to various comments. In writing the preamble, we have avoided counting up the number of comments supporting a given position except in the most general way, believing that doing so would distract from the discussion of substantive issues. Effective Dates The Department has decided to establish an August 1, 2001, effective date for the revised Part 40. We recognize that there is always some difficulty for everyone involved in the transition between an existing rule and a new rule. We hope that this delayed effective date will ease the transition. During the period between publication and August 1, program participants will have the opportunity to learn about new provisions before having to implement them. During this period, the Department expects to develop and issue guidance (e.g., a revised medical review officer (MRO) manual) and make presentations at a significant number of conferences and training sessions. In addition, August 1 is the date on which use of the new Federal Drug Testing Custody and Control Form (CCF), to which the text of the revised Part 40 refers, becomes mandatory. However, we believe it is important to begin implementing some new provisions sooner, since they enhance the fairness and integrity of the process. To do so, we must amend the existing [[Page 79463]] Part 40 to include these provisions, so that they are in effect during the period before the August 1 effective date of the entire new version of the regulation. Come August 1, the existing Part 40 (including the amendments we are issuing today) will be replaced, in its entirety, by the new Part 40. Since the substance of today's amendments will be the same in both versions of the document, there will be no change in how we implement them after August 1. The provisions requiring MRO review and split specimen testing following adulteration and substitution findings will go into effect in 30 days. The majority of laboratories already perform validity testing on a voluntary basis. Making the MRO review and split specimen procedures effective in 30 days will make these additional protections available in connection with this existing validity testing. At the same time, a provision explicitly authorizing the continuation of this existing practice under the new rule will go into effect. To the extent that the Department's September 1998 guidance memorandum concerning adulterated, substituted, dilute, and unsuitable tests is inconsistent with any provisions of these amendments, we regard that guidance as having been superseded on the effective date of the amendments. HHS is currently working mandatory requirements for validity testing. HHS is projecting completion of this project by August 1, 2001. We believe that, to avoid any potential uncertainty about the standards and procedures for mandatory validity testing, DOT should put its mandate for validity testing into effect simultaneously with the new HHS requirements. Consequently, in the event HHS has not issued its new requirements by that date, we will publish a subsequent Federal Register notice postponing the Auust 1, 2001, effective date for mandatory validity testing. Another provision that we are including in the amendments to the existing Part 40, and that will go into effect in 30 days, is the public interest exclusion system. These provisions are very important to ensuring accountability in the provision of drug and alcohol testing. In addition, we are making the provisions of Sec. 40.5 effective in 30 days as Sec. 40.203, since the Department expects to be issuing guidance materials on the new Part 40 before August 1, 2001. For readers' convenience, here is a table of the relationship between the section numbers in the amendments to current Part 40 that go into effect in 30 days and the section numbers of the corresponding sections of the new, revised Part 40 that goes into effect on August 1, 2001: ------------------------------------------------------------------------ Amended current part 40 New revised part 40 ------------------------------------------------------------------------ 40.201.................................... 40.3 40.203.................................... 40.5 40.205.................................... 40.89 40.206.................................... 40.91 40.209.................................... 40.93 40.211.................................... 40.95 40.213.................................... 40.99 40.215.................................... 40.145 40.217.................................... 40.179 40.219.................................... 40.181 40.221.................................... 40.183 40.223.................................... 40.187 40.225.................................... 40.191 Subpart F (same section numbers).......... Subpart R ------------------------------------------------------------------------ Principal Policy Issues In addition to often very detailed paragraph-by-paragraph comments on the text of the NPRM, commenters focused on several major policy issues. These included employee stand-down, validity testing, the public interest exclusion mechanism, the return-to-duty process, transmission of test results and other information through consortia and third-party administrators, reporting and storing information through electronic means, and reporting violations to DOT agencies. Issues also arose concerning confidentiality of information, conflicts of interest among service providers, training, and the collection process. In this preamble, we will discuss these policy issues first. After that, we will proceed to a section-by-section discussion of the rule, including the Department's responses to specific comments. Stand-Down Stand-down refers to an employer practice of temporarily removing an employee from performance of safety-sensitive duties upon learning that the individual had a confirmed laboratory positive drug test, but before the MRO has completed the verification process. The existing regulation prohibits stand-down. MROs are not permitted to inform employers about the existence of a confirmed laboratory positive test pending verification, and employers are not allowed to take any action concerning an employee until they receive the MRO's notification of a verified positive test. The preamble to the NPRM noted the reasons for the current policy: stand-down undercuts the rationale for MRO review, can compromise the confidentiality of test results, and may result in unfair stigmatization of an employee as a drug user. While the rationale for stand-down is that it enhances safety, the Department has no evidence that the current policy has compromised safety. For example, we are not aware of any case in which an employee has had a drug-related accident while verification of a confirmed positive drug test was pending. The preamble also noted that some employers advocated the use of stand-down as a measure to enhance safety and reduce liability. They wanted to use this approach to eliminate, as far as possible, any risk that someone who had tested positive would be involved in an accident before the MRO could complete the verification process. We noted that, essentially for this reason, the Department's own internal drug testing program stood down some employees (e.g., air traffic controllers) in some circumstances following a report of a confirmed positive laboratory test. The NPRM regulatory text proposed two alternatives, one of which prohibited, and the other of which permitted, stand-down. The alternative that permitted stand-down included requirements to help safeguard employees' interests in confidentiality and fairness. Comments Comments were sharply, and fairly evenly, divided on this issue. Some commenters, mostly employers and some service agents, supported stand-down. A few of these comments went further and urged that stand- down be made mandatory, while a greater number said that it should be discretionary with each employer. A smaller number of commenters, including all unions and other employee organizations as well as some employers and service agents, opposed permitting stand-down. The most important argument cited by stand-down supporters was safety. Safety is a more important objective than confidentiality, many of them said. Even if there have not been documented cases of safety problems occurring in the absence of stand-down, no employer wants to be the first to face such a situation. Many employers may feel it so important to stand down employees on safety grounds that they would have an incentive to violate this prohibition. Avoiding unnecessary liability is also a consideration: It would be unwise, commenters said, to force a company to permit an employee it knew had a confirmed positive laboratory test to continue driving a commercial truck or flying a plane during the verification process. [[Page 79464]] Supporters also noted that, in most cases, there were very low rates of confirmed laboratory positive tests being verified negative (indeed, some drugs, like PCP, have no legitimate medical uses that would support a negative verification). Therefore, they said, stand- down would not adversely affect more than the small number of drivers with confirmed positive laboratory results that an MRO later verified negative. Other commenters said that adverse consequences for employees could be minimized by employers choosing to keep employees in non- safety-sensitive positions until verification or ensuring that employees whose tests were ultimately verified negative did not suffer any loss of pay or other adverse consequences. Opponents of stand-down said that the practice embodied a ``guilty until proved innocent'' approach that was manifestly unfair and ignored the purpose of having MRO review of positive tests. Confidentiality provisions would likely be inadequate. In practice, the ``word'' would get out that the employee had a confirmed laboratory test result and the employee--even if the MRO ultimately verified the test as negative--would be stigmatized in the workplace as a drug user. This would upset the regulatory balance between safety interests and the protection of employees from unfair consequences of the process. One motor carrier association said that this would be a particular problem in its industry. In large carriers, an employee cannot be taken out of service without involvement by multiple management employees. For unionized carriers in which assignments are made by seniority, it would be impossible to take a driver out of service without other drivers knowing it. Some commenters contested the safety rationale of stand-down by pointing out that a positive drug test does not indicate impairment. Other commenters said that the risk to the public from the current ``no stand-down'' policy was minimal, given that there were no known instances of accidents resulting from the absence of stand-down. Opponents also cited pay, privacy, and personnel consequences, as well as potential Americans with Disabilities Act and other issues potentially comploicating implementation of stand-down. An associated issue concerns pay status. If a company stands down an employee, should the company be required to pay the employee during this period, pending verification? Several commenters directly addressed this issue. About half of them, including a union and some employers and their associations, favored paying employees while they were in a stand-down status. The remainder said either that the regulation should be silent on the issue, with labor-management negotiations deciding the matter in each case, or that employees should not be paid while in stand-down status. While a number of comments addressed confidentiality and privacy issues, they provided little detail in the way of suggestions for how best to accomplish these objectives in a stand-down situation. Likewise, while a few commenters noted that confidentiality might be a more difficult issue in small companies, they did not provide any suggestions for how to address the issue. There was a suggestion that, to deal with the situation of owner-operators in the motor carrier industry, service agents be empowered to stand down these individuals. DOT Response At the time of the NPRM, the Department recognized enough merit on both sides of this argument to propose alternative provisions. Having reviewed the comments, we remain convinced that advocates of both basic positions on the issue make some strong points. The Department is also aware that potential future changes in drug testing technology, such as the advent of HHS-approved on-site testing and alternative testing methods, may alter the response the Department's procedures take concerning stand-down in the future. Consequently, the Department is taking a middle-ground position on this difficult issue. The general rule will remain that stand-down is prohibited. The reasons for this general rule are the reasons articulated in the existing rule, the NPRM, and the comments from stand-down opponents. However, we believe it is necessary to respond to the genuine and plausible safety concerns of commenters favoring stand-down, the fact that safety is the Department's highest priority, and the fact that the Department's internal program uses a form of stand-down. Therefore, the Department will establish a waiver mechanism that permits employers, on a case-by-case basis, to request DOT agency approval for a specific, well-founded stand-down plan that effectively protect the interests of employees. This approach makes the Department's approach to its internal and external programs consistent with one another. When the Department, in its role as an employer, wanted to use a stand-down approach, it sought and received a waiver from HHS, whose drug testing guidelines also generally prohibit stand-down. Under the final rule, employers in the external program who wish to employ stand-down can, in an analogous way, seek a waiver from the Department of Transportation. We realize that some employers have employees that are regulated by more than one DOT agency. To avoid unnecessary administrative burdens in the waiver process, such an employer would have to submit only one waiver request, to the DOT agency that regulated the largest number of its employees. The various DOT agencies involved would coordinate internally before the lead agency responded to the employer. The Department intends to grant waivers only to employers who present a sound factual basis for their request and will have in place a number of provisions to protect employees' legitimate interests. The final rule (Sec. 40.21) lists several types of information that the employer would submit to the DOT agency in support of its request. This information is intended to give the DOT agency a picture of the employer's organization and safety situation. For example, the size or structure of the organization may affect the ability of an employer to carry out confidentiality requirements for the grant of a waiver. An organization that has an in-house MRO may be in a better position to control access to testing information than one that does not. An organization that stands employees down for reasons other than substance abuse testing may be in a better position to safeguard confidentiality than one that does not. Organizations' drug and alcohol testing history may be a relevant factor in determining whether stand- down is useful in a particular company. None of these kinds of information is intended to establish a litmus test for granting a waiver. DOT agencies will make a case-by- case decision about the merits of a stand-down petition with respect to each company that applies for one. DOT agencies will respond to each petition in writing, with reasons for the decision. DOT agencies are intended to have wide discretion in making these judgments. For example, two companies might present stand-down policies that are nearly identical on paper. However, contextual factors in one company may make its confidentiality assurances credible as a practical matter, while in the other case may suggest that confidentiality could not practically be maintained, despite the company's good faith efforts. DOT agencies could make different decisions in the two cases. We also point out that petitions for waivers [[Page 79465]] will be considered on a company-by-company basis. DOT agencies will not, for example, consider a petition from a trade association or C/TPA on behalf of an industry or segment of an industry. As a condition for receiving a waiver, the rule requires the employer to submit its proposed written stand-down policy. These requirements pertain to confidentiality and protection of legitimate employee interests and are described in greater detail in the discussion of Sec. 40.21 below. One of these requirements is that an employer must continue to pay a worker who is in stand-down status, in the same way it would have in the absence of stand-down. This is a matter of fairness. To assume that the employee's test will be verified positive is to fall into the trap of presuming the employee guilty until proved innocent. In addition, continuing normal pay status for the employee should not be a major burden for employers, given the usually short interval before verification is completed. As a major employer association commented, most employers would not object to paying the employees for a reasonable amount of stand-down time if they believe they will gain a substantial safety benefit. An employer who articulated a safety rationale for stand-down but who objected to paying employees in the brief interim would seem to be an employer reluctant to expend resources commensurate with its expressed commitment to safety. These conditions are intentionally stringent. The Department wants to ensure that only employers who are able to maintain a successful balance between the potential safety benefits of stand-down and the legitimate privacy interests of employees are permitted to operate a stand-down policy. A DOT agency can impose additional conditions on a waiver or, if necessary, revoke a waiver it once granted. A DOT agency could also take enforcement action against an employer that violated the terms of its waiver. Some comments suggested that stand-down be permitted for confirmed laboratory tests for some drugs (e.g., PCP) but not others (e.g., opiates), based primarily on the lower or higher probabilities of verified negatives for these substances. The Department is not including such a provision as a general matter, out of concern that such a provision might lead to confusion. Public Interest Exclusions (PIE) The NPRM proposed that service agents--persons and organizations that provide drug and alcohol testing services to employers, such as laboratories, MROs, substance abuse professionals (SAPs), collectors, breath alcohol technicians (BATs), screening test technicians (STTs), consortia and third-party administrators (C/TPAs)--should be accountable for serious noncompliance with Part 40. The NPRM proposed a mechanism based on the Department's existing non-procurement suspension and debarment rules (49 CFR part 29). This mechanism would permit the Department, following a series of procedures designed to ensure fairness, to impose a public interest exclusion (PIE). A PIE would direct DOT-regulated employers not to use the service agent for a period of time. The Department proposed to use this mechanism only in cases of serious misconduct where the service agent has not implemented prompt corrective action following notice by a DOT agency. The preamble noted that this mechanism rested on the Department's existing authority to establish requirements for the conduct of the drug and alcohol testing process and to direct employers to use only products and services that met these standards. Comments The PIE proposal generated a good deal of comment. Almost a hundred written comments to the docket addressed the proposal, which was also the subject of extended discussion at the Department's three listening sessions, where the Department convened forums specifically on the subject. A strong majority of employers and all unions addressing the proposal favored it. Among service agents and their organizations, and other commenters submitting written comments, about 60 percent opposed the proposal, as written. Some service agent commenters urged postponing consideration of the provision and addressing it in a separate rulemaking. Even the commenters who opposed the proposal said that they believed service agents should be accountable for their conduct, at least in principle. Their reasons for opposing the proposal included doubting the need for such a mechanism and the Department's authority to implement it, a belief that the proposed process was insufficiently defined and did not provide enough procedural safeguards for service agents, a concern that DOT auditors and inspectors might initiate PIE proceedings arbitrarily, a preference for other alternatives (e.g., additional industry standards, certification, training programs, litigation), or support for other options mentioned in the preamble to the NPRM (e.g., certification or self-certification by all service agents with a DOT decertification process). Proponents of the proposal cited examples of misconduct by service agents for which there was no present remedy. They said that employers, especially small employers, often had to take on faith the quality of service agents, and the PIE process could help them to know which service agents to avoid. Employers also believed that it was unfair for them to be solely accountable for serious problems in the testing process. Service agents who supported the proposal said that it would enhance the overall quality of performance by service agents. Some service agents cut corners to reduce costs, putting more conscientious service agents at a competitive disadvantage, these commenters said, and then ``whined'' when the Department proposed a meaningful accountability mechanism. Commenters had a number of thoughts on specific aspects of the proposal. Many asked for greater specificity concerning the kinds of ``offenses'' that would lead to a PIE proceeding. DOT staff pointed out, during the listening sessions and in writing, that the PIE mechanism was intended, both for policy and resource reasons, to be used only in the case of ``egregious'' misconduct. However, commenters pointed out that this statement was not made in the proposed regulatory text. They feared that differences in interpretation among inspectors and other DOT staff could lead to the inconsistent or arbitrary use of PIE proceedings. Some of these commenters desired a specific list of the actions that would lead to a PIE proceeding, while others suggested the Department should at least provide examples. Another frequently-made comment concerned the scope of PIEs. The NPRM said that a PIE would apply to all divisions, organizational elements, and types of services provided by a service agent, unless the ODAPC Director decided to limit its scope. Affiliates and individual officers and employees could also be subject to a PIE. A number of service agents and employers objected to this aspect of the proposal, saying it was too broad. It was unfair, they said, to prohibit employers from using a service agent's other services because of a problem in one area. If a TPA has violated the rule with respect to MRO services, for example, why should a PIE prevent an employer from using the TPA for collection or SAP services? Many commenters who made this point favored an approach that came to be known, in the listening sessions, as the [[Page 79466]] ``slice of PIE.'' Under this approach, a PIE would apply only to the type of service in which noncompliance had taken place. Some commenters said the ``slice'' should be even narrower, applying only to the specific employer, facility, or individual service agent staff members who had been involved in the noncompliance. A few laboratories said that laboratories should not be subject to the PIE process, since HHS already regulates laboratories through its certification process. Another commenter thought that it would be better to fine erring service agents rather than issuing a PIE. Commenters raised two issues concerning the role of the ODAPC Director in the PIE process. A few service agents suggested that the Director would not be an objective decisionmaker, because he or she would be too sympathetic to the position of DOT staff. Others suggested that the ``firewall'' between the Director and other staff be made more explicit in the regulatory text. Several service agent commenters also asked for criteria for determining the length of a PIE, as well as a regulatory time frame for the Director's consideration of a service agent's petition to lift a PIE. Smaller numbers of commenters suggested other procedural changes in the PIE provisions. One recommendation was that the initiating official's burden of proof be ``clear and convincing evidence'' instead of a preponderance of the evidence. Others asked for specific rules of evidence to apply to PIE proceedings. Some asked that the Department contact the service agent first, to check on alleged facts, before initiating a proceeding. A number of employers asked for periods longer than the proposed 90 days to replace a service agent that was subject to a PIE, or for the possibility of extensions of that period. Some service agents asked to delay the effective date of the PIE provision by a year or two, to give organizations time to get used to the requirements of the new final rule. A commenter asked that the rule provide for a private right of action by employers against service agents. Other commenters disagreed with the statement in the proposed rule text that the purpose of a PIE was not punishment. DOT Response 1. Basic Rationale for the PIE Provisions Service agents perform the bulk of drug and alcohol testing services for transportation employers. Employers, particularly small employers, necessarily rely on service agents to comply with their testing obligations. These employers often do not have the expertise in testing matters that would enable them to evaluate independently the quality, or even the regulatory compliance, of the work that service agents perform for them. Yet an employer's compliance with DOT regulations is largely dependent on its service agents' performance. If a service agent makes a serious mistake that results in the employer being out of compliance with a DOT rule, the employer alone is now accountable. The employer may be subject to civil penalties from a DOT agency. The employer can be subject to litigation resulting from personnel action it took on the basis of the service agent's noncomplying services. Most importantly, the employer's efforts to ensure the safety of its operations may be damaged, as when an employee who apparently uses drugs is returned to duty because of a service agent's noncompliance. In many cases, there are now no consequences to a service agent who creates such problems, even if the problems are serious. The experience of DOT agencies, which are responsible for reviewing employers' compliance, is that the vast majority of employer noncompliance results from service agent errors. (Given the pervasive role of service agents in performing testing functions, this is probably not a disproportionate effect.) FAA staff informally estimate, for example, that more than nine out of ten deficiencies their inspectors discover result from service agent errors. In addition, the Department's drug and alcohol testing office staff, from time to time, encounter serious noncompliance with DOT rules by service agents, for which there is no present remedy. Here are a few examples of actual cases we have encountered: An MRO verified many tests positive without conducting verification interviews. As a result, the tests had to be cancelled, and the employer had to return the employees to duty, incurring extra safety risks and costs. Another MRO, who had counterfeit medical credentials, verified several tests positive, bringing into question the integrity of the verification process. In defiance of the clear language of Part 40, a letter from the Department, and a finding by a court, a laboratory refused to provide an employee information to which she was entitled. A service agent made false claims that its personnel were certified by DOT. DOT wrote them a letter telling them to stop. Years later, the same service agent's letterhead continues to make the same claims. A consortium and a laboratory were engaged in a billing dispute with one another. As a result, numerous pre-employment results were not transmitted to employers for a number of months. No one informed the employers of the problem, and some of the employers, in the apparent belief that ``no news is good news,'' placed some of the workers--including one who tested positive--in safety-sensitive positions. A major employer used a service agent for SAP services. The SAPs provided by the service agent established a long-standing pattern of returning virtually all employees who have tested positive to work quickly, without education or treatment. Personnel of a major laboratory engaged in misconduct apparently involving the backdating and attempted destruction of documents relevant to litigation concerning a drug test result. Attempting to deal with service agent problems one employer at a time is both inefficient and potentially unfair. It is inefficient because service agents work for many employers. It is potentially unfair because employers may be unwitting victims of service agent misconduct. Conducting civil penalty proceedings against several employers because of the actions of one service agent, moreover, does little if anything to correct the conduct of the service agent or protect other employers from the consequences of its noncompliance. In addition, service agents often work for employers in more than one transportation industry. For example, if FRA takes action with respect to a railroad whose noncompliance is caused by service agent errors, this does nothing to protect a motor carrier who uses the same service agent. The Department believes that, in this situation, an accountability mechanism that protects the public interest, employers, and employees is appropriate and necessary. A few commenters appear to have misunderstood the nature of the PIE proposal. It is not an assertion of new regulatory authority over service agents. It makes use of the Department's long-standing authority to direct transportation employers not to use products and services that do not meet Federal standards. Employers may not use laboratories that are not HHS-certified. They may not use evidential breath testing devices (EBTs) that are not on the National Highway Traffic Safety Administration (NHTSA) conforming products list (CPL). They may not use SAPs and MROs who fail to meet regulatory qualifications. There is no difference in legal principle [[Page 79467]] between these well-established prohibitions and a requirement not to use a service agent who has been found to have seriously noncomplied with Part 40. A PIE is simply one additional directive to transportation employers to ensure that the employers use only service providers that meet regulatory requirements. Procedurally, the PIE process is modeled on a well-established procedure for handling non-procurement suspensions and debarments. While not identical to the non-procurement suspension and debarment rules of the Department (49 CFR part 29), the PIE process draws on Part 29 for many of its details. Modeling PIE on an existing program that affords due process to participants ensures that PIE will be an effective and fair approach to serious noncompliance in the drug and alcohol testing program. 2. Legal Authority The Department looked carefully at the issue of legal authority before proposing the PIE process in the NPRM. As noted in the preamble to that document, there is ample legal authority to implement this proposal. First, there is specific statutory authority for rulemaking in this area. Section 322 of the DOT Act provides general rulemaking authority to the Secretary of Transportation. It states that ``[t]he Secretary of Transportation may prescribe regulations to carry out the duties and powers of the Secretary.'' Further, the 1991 Omnibus Act authorizes the Secretary of Transportation to continue in effect, amend, or further supplement regulations governing the use of alcohol or a controlled substance. See 49 U.S.C. 31306(i), 49 U.S.C. 20140(f), 49 U.S.C. 5331(f)(3), and 49 U.S.C. 45106(c). Upon review of the Act, it is clear that Congress--while not explicitly mentioning a particular mechanism to ensure compliance--intended the Secretary to use his or her discretion to devise appropriate regulatory methods to carry out the Department's drug and alcohol testing responsibilities. Moreover, under well-settled case law, specific statutory authority is not needed in order for an agency to have authority to impose a reasonable requirement. There are many court decisions that support this point, particularly cas","truncated":true,"body_characters":818230}