4910-62U
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 bob.ashby@ost.dot.gov (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
mary.bernstein@ost.dot.gov (e-mail); or Jim L. Swart, Drug and Alcohol Policy Advisor, ODAPC ,
same address and phone numbers as above, 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. 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 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 §40.5 effective in 30 days as §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.
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 (§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 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 §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 "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 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 cases following Chevron v. Natural Resources Defense Council, 467 U.S. 837 (1984). Chevron stands for the proposition that courts will defer to "permissible" agency interpretations where the statute is "silent or ambiguous". In Chevron, the leading case on the regulatory and interpretive authority of agencies, the Supreme Court articulated the following standard:
When a court reviews an agency's construction of the statute it administers, it is confronted with two questions. First, always, is the question of whether Congress has directly spoken to the precise question at issue. If the intent of Congress is clear, that is the end of the matter; for the court, as well as the agency, must give effect to the unambiguously expressed intent of Congress. If, however, the court determines Congress has not directly addressed the precise question at issue, the court does not simply impose its own construction of the statute, as would be necessary in the absence of an administrative interpretation. Rather, if the statute is silent or ambiguous with respect to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute. (Id. at 842-43).
Numerous cases have reaffirmed this standard. When courts have applied the Chevron analysis to strike down an agency regulation or interpretation, they have not done so on the basis that a statute did not speak to the issue at hand. Rather, they did so because something in the statute specifically precluded the action the agency had taken. It is clear that nothing in the Department's statutes precludes the Department from instituting a procedure like PIE.
To the contrary, the most important statute authorizing the DOT drug and alcohol testing program, the Omnibus Transportation Employee Testing Act of 1991, confirms the Department's broad authority to carry out its drug and alcohol testing responsibilities. Congress intended that the Secretary use his or her discretion and issue supplementing regulations when necessary to carry out the Department's drug and alcohol testing responsibilities.
The DOT agency drug testing regulations and Part 40 were originally adopted in 1988-89 without any specific statutory authority. These rules were based on the DOT agencies' general safety rulemaking authority and the Department's general rulemaking authority. These DOT agency safety statutes are silent with respect to drug and alcohol testing. They do not describe drugs to be tested, types of tests, random testing rates, laboratories, medical review officers, return-to-duty procedures, testing equipment or personnel, or any of the other subjects addressed by DOT agency substance testing rules and Part 40. Before the Omnibus Act, these statutes provided the only authority for the DOT agency drug testing rules, and they still provide the only authority for the RSPA and Coast Guard rules. There was never any question -- aside from the original transit rule -- about the authority of the DOT agencies to issue these rules. When plaintiffs challenged these rules, they and the courts focused on the constitutional issues, mentioning the agency's authority for the rules only in passing, since it was so clear.
Under Chevron, when the intent of Congress is clear, as is the case here, no further inquiry is necessary. This makes it unnecessary for any reviewing court to move on to the second prong of Chevron. If a court did examine the PIE provision under the second prong however, there is little doubt that the Department's action is based on a permissible construction of the statute. The Department 's decision to facilitate employer compliance and protect employers and employees from the consequences of services that are inconsistent with regulatory requirements is reasonable. Each of the requirements of Part 40 is important to ensure the accuracy, integrity, privacy and fairness of the testing process as well as the safety of the public. If a service agent fails or refuses to meet these requirements, then these important interests are adversely affected.
As the testing program and the role of service agents have evolved over ten years, the Department has learned that additional measures are needed to ensure the proper provision of testing services to employers. In every respect, the proposed PIE process comes squarely within the range of agency actions which courts, applying Chevron, have approved.
3. Alternatives
The Department believes that efforts by industry groups to establish certification programs, training programs, and industry standards are laudable and helpful. Such efforts, however, do not address the issue of accountability for service agents whose noncompliance is serious. These programs cannot respond, in a legally binding way, with real consequences, to protect employers and employees from the misconduct of a party who makes serious errors or chooses to noncomply to gain an economic advantage.
An accountability mechanism like that proposed in the NPRM would effectively complement voluntary industry efforts. By attaching tangible consequences to serious noncompliance, an accountability mechanism would assist industry groups in getting service agents to take certification, training, and industry standards programs seriously.
Some commenters favored one or more of the options discussed in the NPRM preamble, such as certification or self-certification followed by a DOT decertification procedure or a contract-based mechanism. With respect to the contract mechanism, comment was, however, very divided, with many commenters (in response to the PIE proposals or proposed §40.11) saying that the contract clause requirement was too burdensome or ineffective (i.e., with respect to parties who typically do not have written contracts). The Department does not have the resources to operate a Department-wide active certification program (especially with respect to the motor carrier industry). Maintaining a data base for a self-certification program would be difficult for the Department, and there are significant issues concerning keeping such a data base up to date. For these reasons, we do not believe that these options are preferable to the PIE provisions the NPRM proposed.
A few commenters supported reliance on the legal system (i.e., court litigation) as a tool for employers to use to address problems caused by service agent noncompliance. Nothing prevents employers from resorting to private litigation now or in the future. By nature, however, such private litigation focuses on vindicating the private interests of the employer involved, not in more broadly protecting testing program participants and the public interest. For this reason, we do not view private litigation as a substitute for the PIE provisions.
4. How does a PIE proceeding begin?
Many service agent commenters asked for greater clarity and specificity concerning what "offenses" would be sufficient to warrant starting a PIE proceeding. They expressed the concern that the NPRM proposal would give DOT officials, including auditors and inspectors, too much discretion to start PIE proceedings based on minor problems, despite the Department's statements that PIEs were intended to be used in cases of "egregious" noncompliance.
As DOT officials said during the listening sessions in PIE roundtables, we do not think it is a good idea to have a definitive list of offenses that would trigger a proceeding. The Department's experience with this program suggests that new situations will always arise. We cannot possibly specify them all at this time. A list that appeared definitive could lead to arguments that the Department was precluded from starting a PIE proceeding because the underlying conduct was not on a regulatory list.
Nevertheless, the Department does believe it would make our intent and policy clearer to state in the regulatory text that this process is intended to be used only for serious noncompliance. We provide several examples of the kind of noncompliance that would, as a policy matter, have a level of seriousness sufficient to warrant starting a PIE proceeding. This regulatory text provision also states that the list is not exclusive or exhaustive: we retain the discretion to start PIE proceedings in situations not on the list and we are not required to start a PIE proceeding every time something on the list comes up.
We also make clear that not everyone with a DOT ID card is authorized to start a PIE proceeding. Only certain officials, such as DOT agency drug and alcohol program managers, are authorized to do so. They may rely on credible information from any source, including but not limited to DOT auditors and inspectors, as the basis for starting a proceeding. As several commenters requested, the final rule text provides that the initiating official must contact the service agent to get its side of the story and any facts it can provide before taking further action, such as issuing a correction notice or a notice of proposed exclusion (NOPE).
One issue on which commenters spoke concerns the relationship of the PIE process and the HHS certification process for laboratories. With respect to matters on which HHS takes certification action against a laboratory, the Department would defer to the HHS action. That is, as a policy matter, the Department would not start a PIE action is HHS had already taken a certification action against a laboratory on the same matter. We do not believe it would be an economical use of resources to have two Federal proceedings in progress with respect to the same laboratory, on the same issues, at the same time. However, if DHHS decided that it was not appropriate to begin certification action (e.g., because the laboratory's conduct did not trigger the HHS "imminent harm" standard), DOT could consider whether to begin a PIE proceeding.
One of the concerns that some commenters expressed was that the very existence of a PIE proceeding, regardless of its ultimate outcome, could have adverse economic effects on a service agent. They asked that such proceedings be kept confidential. The Department does not believe that it is possible to keep a PIE proceeding, or the events leading up to it (e.g., a factual inquiry, a correction notice) secret. For example, in seeking to establish whether there is a factual basis for a PIE proceeding, DOT personnel might well have to ask questions of a number of employers about the service agent's activities. On the other hand, the Department will not affirmatively seek to make pending proceedings public knowledge, prior to the issuance of a NOPE. For example, we do not intend to issue a press release or make other kinds of public announcements at the time that we send a correction notice to a service agent. The issuance of a NOPE and the Director's decision, however, are matters of public record.
5. Scope of PIE proceedings
Section 40.379 of the NPRM proposed that a PIE would apply to all the divisions, organizational elements, and types of services provided by the service agent involved, unless the Director limited the scope of the proceeding. Under some circumstances, affiliates and individuals could also be subject to a PIE. Many service agent commenters thought the scope of a PIE should be narrower, limited to a particular type of activity, affected employer, etc.
The intent of the PIE proposal is to protect the public from the misconduct of an organization. Allowing the organization to segment its activities, and contend that the public should be protected only from some of what it does, is contrary to this objective. Nevertheless, the Department believes that it is appropriate to decide, on a case-by-case basis, whether a compliance problem is limited to one facet of a service agent's activities or pervades the service agent's organization. The Department is therefore making a procedural change from the NPRM. Instead of saying that a PIE would apply to everything a service agent does, the final rule makes the scope of the PIE an issue in the proceeding.
That is, the initiating official would propose a scope for the proposed PIE, depending on that official's view of how pervasive the noncompliance was in the service agent's organization. It might be one activity or organizational element; it might be more than one; it might be the totality of the service agent's activities. The service agent could contest the initiating official's scope proposal, and the Director would make an explicit decision about scope. This is not quite the "slice of pie" proposal advanced by some service agents, since the Department would not necessarily be limited by rule to applying a PIE only to the type of activity or organizational element directly involved in the noncompliance. But the initiating official would have the burden of persuading the Director that the proposed scope of the PIE was appropriate in light of the facts of the case. The final rule text provides several examples to illustrate the way this scope procedure is intended to work.
6. Procedural Issues
Like the NPRM, the final rule requires initiating officials to send a correction notice to a service agent before starting a PIE proceeding. This notice gives the service agent 60 days to fix a problem or change its procedures before a more adversarial process begins. We have added greater specificity concerning the NOPE that begins a PIE proceeding (e.g., specifically requiring information on the proposed scope and duration of the PIE).
We believe that the ODAPC Director is the appropriate person to make decisions in PIE cases. The ODAPC Director is someone who is knowledgeable about the DOT program and regulations but who is not directly involved in their enforcement by the DOT agencies. We disagree with contentions that the Director is inherently biased in potential PIE matters. It is the Director's job to consider such matters fairly and in accordance with the Department's rules, and nothing in the comments persuades us that the Director will be unable to do the job right.
To reassure participants further about the objectivity of the process, we have added language to the final rule specifically prohibiting the ODAPC Director from playing any role in the initiation of a PIE and establishing a "firewall" between the initiating official and the Director. This firewall would prohibit any ex parte contacts between the two. In any situation in which it would be inappropriate for the Director to act as the decisionmaker (e.g., the Director had recent professional ties to the service agent who was the subject of the PIE proceeding, the Director has had substantial involvement in a matter before it becomes the subject of a PIE proceeding), the rule the Director would designate another person to decide the case. In addition, the final rule lists the elements of the Director's decision, including not only the basic decision about whether to issue a PIE but also decisions about disputed matters of material fact, the scope of a PIE, and the duration of a PIE.
The standard of proof in a PIE proceeding will remain "the preponderance of the evidence." There is no policy or legal basis apparent for raising this burden to the higher "clear and convincing evidence" level. Contrary to a few comments, there is no "presumption of guilt" on the part of a service agent in a PIE proceeding. The initiating official bears the burden of proof. Administrative proceedings in many kinds of matters, including suspension and debarment proceedings under Part 29, are conducted informally, without formal rules of evidence of the kind used in the court system, with evidence accepted on a general relevance standard. The final rule makes clear that PIE proceedings will be conducted in this way.
The Department takes no position on whether Part 40 creates a private right of action, deferring to the courts or to DOT agency regulations on this issue. While the Department recognizes that a PIE will have adverse consequences for a service agent, we continue to believe that the purpose of a PIE is to protect the public interest, not punishment. This language, which is derived from Part 29, is an accurate statement of the intent of the PIE provision and we are retaining it. A few commenters asked for a time frame for PIE decisions by the Department. We have responded by saying that the Director will generally make a decision within 60 days of the completion of the record in the case, though the Director can extend this period for good cause.
Some commenters requested additional clarification of the standards for determining the duration of a PIE. In response, we have added a new section listing examples of the kinds of factors that the Director will consider in determining the appropriateness, scope, and duration of a PIE. Since the proposed duration of a PIE is one of the elements of a proceeding that service agents can contest, service agents and initiating officials will have the opportunity to refer to these factors in their arguments about duration. In general, we say in the final regulatory text that a PIE stays in effect for one to five years. In deciding on the duration of a PIE, the Director will take into account the seriousness of the noncompliance and other factors listed in the rule. Nine months after the Director issues a PIE, the service agent can apply to the Director in writing to terminate or reduce a PIE. The rule spells out the grounds for such a request.
As noted in the "Effective Dates" section of the preamble, the Department is making the PIE provisions
of the rule 30 days from the date of publication. The effect of this action is to make PIE proceedings
available to the Department with respect to noncompliance with the existing Part 40 rule between the
publication date of this revision and the August 1 effective date of the complete revised Part 40. We are
doing so in order to emphasize to service agents that they are accountable for their actions. In some
recent instances (e.g., the apparent laboratory evidence tampering incident referred to in "Basic
Rationale for PIE Provisions" above), the Department would have had grounds for considering the use
of PIE proceedings, had they been available to us.
Return-to-Duty Process
The NPRM raised a number of issues surrounding the return-to-duty process. We proposed to consolidate this material in Part 40. One issue concerned the minimum number of follow-up tests that SAPs should prescribe. Should there be an increase over the current rule's requirement of six tests over the first 12 months following an employee's return to duty (e.g., to 12 tests over one or two years)? Another issue was "aftercare." That is, SAPs often make recommendations for continuing assistance after the employee returns to work. The NPRM proposed that employers would have to monitor employees' compliance with these recommendations. A third issue was whether SAPs should routinely receive drug test quantitations.
Comments
Comments from a mixture of employers, employees, and service agents directly addressed the question of whether the Department should increase the minimum number of follow-up tests. A substantial majority of these commenters opposed any change in the current requirement of a minimum of six tests over the first year following the employee's return to duty, and a few of these suggested reducing that minimum. These commenters did not oppose retaining the SAP's discretion to prescribe a higher number of tests or testing that went beyond the first year. Some additional commenters said that number of tests should be determined at the SAP's discretion, or in negotiation between the SAP and employer. On the other hand, a few commenters favored increasing the minimum to 12 tests.
With respect to aftercare, several motor carriers and motor carrier associations opposed the proposal for employers to monitor employee compliance with SAP recommendations. They said it would be too burdensome and went beyond their expertise, which centered on running trucks, not aftercare. A few service agents supported the proposed change. There was also concern expressed, principally in discussions at the listening sessions, that some SAPs were reluctant to recommend assistance even after employees tested positive, whether out of over-reliance on employee's excuses, claims that the testing process was flawed, or the SAP's personal opinions about the justification for or utility of the testing process. Some commenters asserted that the very fact of a violation showed that an individual was in need of some education or treatment, so it was inconsistent with the purpose of the rules to permit SAPs to find that an individual was not in need of assistance.
Commenters were divided on the issue of whether SAPs should routinely receive reports of the quantitation of drugs in the specimens of individuals who tested positive. Those who favored this approach, including most of the employers who spoke to this issue and some of the SAPs, said that it would be useful to know the levels of drugs in the employees' specimens. This would be helpful to SAPs as they try to evaluate an employee's situation and determine what sort of treatment was appropriate. The majority of commenters opposed providing this information on a routine basis, saying that the quantitation of drugs in a specimen was usually irrelevant to evaluation and treatment and could sometimes be diagnostically misleading. Testing was never intended to diagnose addiction, and urine test quantitations rarely provide a good basis for evaluating an employee's drug problems. A laboratory added that requiring laboratories to report this information to SAPs would be burdensome.
DOT Response
With respect to follow-up tests, the Department has decided that it is not necessary to increase the minimum number. We believe that follow-up tests are very important. They are the best tool we have to make sure that an individual who has returned to duty after a violation remains in compliance while experiencing the actual stresses and temptations of the work environment. However, requiring a greater number of tests could be unnecessarily burdensome in those cases in which SAPs are satisfied that six tests are sufficient. We will keep in place the basic provisions of the existing rule: a minimum of six such tests in the first year of safety-sensitive work following the employee's return to duty. SAPs will continue to have discretion to require a greater number of tests over a period of up to 60 months, as in the current rule.
The Department has become convinced that there is no basis for a SAP ever determining that an individual who has tested positive or otherwise violated the drug and alcohol rules does not need education or treatment as well as follow up testing. For someone who performs safety-sensitive transportation functions, the very fact of a violation indicates a disregard of safety that must be addressed, corrected, and monitored in order to ensure safe performance of those functions in the future. Therefore, the final rule will require the SAP to mandate some level of assistance in every case, as well as to prescribe at least the minimum number of follow-up tests for each employee who returns to duty following any violation of the rules. We also clarify that the SAP must present a copy of his or her written follow-up testing plan to the designated employer representative (DER). The rule text also cautions SAPs against basing any decisions, even in part, on employee claims of flaws in the testing process or any private opinions of the SAP about the validity or utility of the testing process.
In response to comments, the regulation clarifies that the follow-up testing requirement follows the employee from one job to another and persists through a break in service. That is, if after returning to duty with an employer, the employee changes jobs before completing all required follow-up tests, the employee is responsible for completing the follow-up tests with his or her new employer. Likewise, if the employee returns to work, is laid off for several months, and then comes back to work with the same employer, the employee must complete the series of follow-up tests ordered by the SAP.
With respect to employer monitoring of aftercare, the Department is persuaded by the objections of employer commenters that we should not require employers to take on this task. SAPs have the obligation to make recommendations for aftercare where they believe such assistance is needed to maintain sobriety or abstinence from illegal drugs. These recommendations should carry a good deal of weight, because they in effect declare that employee compliance with them is important to ensure safe performance of safety-sensitive functions. The rule states the employee's obligation to comply with these recommendations.
Rather than requiring employer monitoring, however, the rule provides the employer discretion to take a variety of steps. These could include putting compliance with SAP recommendations into return-to-duty agreements, disciplining employees for noncompliance, and using the services of SAPs or employee assistance programs (EAPs) to assist and monitor employees' aftercare activities. The rule notes that employers can choose to monitor these activities, and that employees who fail to carry out the recommendations can be subject to sanctions from their employers. We note that this discussion concerns employer discretion with respect to aftercare (e.g., treatment and education) activities only. Employers do not have discretion with respect to follow-up tests. Employers must carry out the follow-up test instructions they receive from SAPs.
The Department believes that the commenters who opposed routinely providing drug test quantitations to SAPs have the better of the argument. SAPs take a variety of factors - including a face-to-face interview with the employee - into account when determining what assistance the employee needs. The amount of a particular drug in an employee's specimen at a particular time does not determine what sort of treatment is most appropriate for the individual. Consequently, we will not provide for quantitations to be given to SAPs on a routine basis. We do provide, however, that SAPs can consult with MROs (who must cooperate with SAPs) and receive information that the MRO has gathered as part of the verification process. Through this process, SAPs can get additional information that may be of use to them in the evaluation process.
We want to emphasize that neither the rule nor the Department's require employers to fire employees who violate the Department's drug and alcohol testing rules. There is no national policy, and certainly no policy articulated by the Federal government, that commands this result. We would not have this detailed return-to-duty procedure if we believed that no one should be returned to duty after a violation.
As has been true from the beginning, all the Department requires is that an employee who violates the rule not perform safety-sensitive functions until and unless he or she successfully completes the return-to-duty process. Decisions about discipline and termination are left to the discretion of the employer or labor-management negotiations. Where employer policy, or labor-management negotiations, have delegated personnel decisions of this kind to an arbitrator, the Department intends that the arbitrator's decision determines the personnel action that the employer takes. The Supreme Court has recently affirmed these principles. Eastern Associated Coal Corporation v. United Mine Workers of America, District 17, et. al, 531 U.S. ___ (2000).
Of course, an arbitrator cannot order an employer to return an employee to the performance of
safety-sensitive functions until the employee has successfully completed the return-to-duty process. Nor
can an arbitrator or an employer change the laboratory's findings about a specimen or an MRO's
decision about whether there is a legitimate medical explanation for a test result.
Collector Training
Competent performance of drug and alcohol testing functions by collectors, BATs and STTs, MROs, SAPs and others involved in the testing process is obviously very important to the integrity and fairness of the Department's program. The Department's NPRM asked questions and offered proposals for the training and qualifications of these personnel. This discussion focuses on collector training, which was the subject of more comment than training for other personnel. Training and qualifications for other personnel are discussed in the section-by-section portion of the preamble.
Comments
Training for collectors in the drug testing program was the subject of comment from a wide variety of parties, including service agents, employers, and unions. Commenters differed on most of the subjects under discussion, including the basic point of the extent of current problems in the collection area. Most commenters on the subject believed that collections were the weakest point of the testing process, though some argued that there was a low rate of collection errors in their experience. Some commenters said that it would reduce collection errors if the Federal Custody and Control Form (CCF) were simplified.
Some commenters favored a formal instruction course for collectors, like the Department's BAT course. Most of these and some other commenters opposed the notions of self-instruction and self-certification for collectors, saying that they were meaningless. They believed that there should be some sort of formal training, with an examination or other means of ensuring that a collector deserved to be certified. Some commenters also supported a "train-the-trainer" course requirement to certify trainers.
Other commenters, however, opposed any formal training requirements for collectors, saying it was expensive, burdensome, and might make it harder to find collectors, especially in less densely populated areas. A maritime employer group asked for some exceptions to training requirements for people who were not regularly collectors but might occasionally have to conduct a collection, as in a post-accident situation.
Commenters who thought the NPRM's training proposals were too extensive often objected to requirements for classroom training or other training modes involving a live instructor or monitor. They said the requirements should be more flexible, and provide for training through such approaches as videos, internet-based courses, or instruction and monitoring through telephone or interactive computer methods.
A number of commenters objected to the term "sufficiently knowledgeable," which the NPRM used to describe the personnel who trained collectors. The commenters said the term was too vague. Some of these commenters asked that the rule include more specific qualifications for trainers. Some commenters also objected to the proposal that trainees be required to complete five error-free mock collections, saying that the requirement was either too burdensome (some suggested the number of mock collections be reduced) or insufficient. Some commenters also took issue with the requirement that a collector who made a "fatal flaw" mistake should have to be retrained, particularly since they felt it might threaten the validity of subsequent collections the collector conducted prior to the retraining. Others thought it would be better to have a slower trigger for the retraining requirement (e.g., two fatal flaws in two years).
DOT Response
The Department believes that making collector training more effective will be an important step in reducing errors in the drug testing process. The collection of urine specimens is the step in the process with the greatest potential for administrative error, and our own experience confirms the comments of persons who said that collections are a fertile source of mistakes. When our inspectors and program personnel visit collection sites in the field, they commonly find a wide variety of mistakes and misunderstandings in the collection process. We also agree that self-certification is inadequate. For these reasons, we will require additional training of collectors, compared to the present rule. We believe that this training should be provided in as flexible a manner as possible. Section 40.33 contains the Department's resolution of collector training issues.
Part 40 contains much information about how collections must be conducted. It is essential that collectors become knowledgeable about the relevant portions of the new Part 40, DOT collections guidance and relevant DOT agency rule provisions, and we will require them to do so. We also believe that more formal training is needed to ensure that collectors understand and can carry out the requirements of this part. We believe that, as commenters noted, the training can be provided in a number of ways (e.g., classroom sessions, videos, internet courses). We are not prescribing a particular curriculum as we have for alcohol testing personnel, and we will not require that collectors be "certified." By taking this approach, we achieve the objective of additional training while allowing flexibility and minimizing costs. In-person involvement of a trainer is not required for this part of the training process.
To demonstrate that they can practically apply what they have learned, collectors must conduct five consecutive error-free mock collections. We believe this is an extremely important requirement, because collectors must deal with real people and real specimens in their job, not just regulatory text or computer simulations. By mock collections, we mean collections that are not real collections of employees subject to testing under DOT regulations. The five collections must include both uneventful and "problem" testing scenarios. Another person must monitor and evaluate the mock collections to ensure that they are error-free. This part of the process does involve the in-person participation of someone to monitor and evaluate the trainee's performance (unless some technology is used that permits the real-time, step-by-step observation and evaluation of the trainee's performance without a person in the same room with the trainee).
The monitor must be someone who has demonstrated necessary knowledge, skills, and experience (1) by regularly conducting DOT drug test collections for a period of at least a year, (2) by having conducted collector training under this part for a year, or (3) by successfully having completed a "train-the-trainer" course. The Department sets out these alternatives for qualifying as a trainer in response to comments that said "sufficiently knowledgeable" was too vague.
All new collectors must meet these training requirements. In addition, current collectors must meet the requirement within 2 1/2 years after the effective date of this rule (December 2003). This will provide adequate time for current collectors to get the necessary qualification training, if they have not already done so.
Collectors would have to get refresher training every five years. We believe that, just as other professionals in the drug and alcohol testing business need continuing education, it is important for collectors to brush up on the rules and techniques of their part of the drug testing process, in order to ensure that they perform at the highest level. This training would also focus on any changes in collection technology that had come into use in the meantime.
One of the most important occasions for training is following a mistake that actually results in a test being cancelled. This requirement does not apply every time there is a cancelled test, only when the cancellation is the result of the collector's error. The training would focus on the subject matter that was involved with the error, and would also involve three monitored error-free mock collections. This training would have to take place within 30 days of the collector's being notified of the error. The reason for this training is obvious: if someone makes a mistake once, we want to make sure he or she does not make a similar mistake again.
Commenters noted that it might be very burdensome for employers, or even some service agents, to
keep training records for each of their possible many and widespread collectors. To avoid this problem,
we are requiring that collectors (like other service providers) keep their own training records, which
would have to be made available to employers, other service agents (e.g., C/TPAs) involved with the
collector's provision of services, and DOT. In addition, we specify in §40.209 that a test is not
invalidated because a collector has not fulfilled a training requirement. For example, suppose someone
collects a specimen correctly but has not completed required training or retraining. The test would not
be cancelled because the training requirement was not met, though the collector, other service agents,
and employer involved might be found in noncompliance as the result of the failure to meet training requirements.
Transmission of Information through Consortia and Third-Party Administrators
When the Department began the drug testing program in 1988-89, we had in mind a perhaps simplistic model of how the program would work. We imagined that most employers would have an in-house testing program that would perform most of the tasks the rules required, except that employers would contract directly with laboratories for specimen testing services and perhaps with MROs for medical review services. We thought that owner-operators and other very small employers might well band together in consortia to gain economies of scale in purchasing testing-related services.
The program has developed in quite different directions, to the point where most employers' drug and alcohol testing programs are outsourced, often operated by C/TPAs. These organizations often bundle their services to employers. Only a minority of employers, usually large ones, operate their own programs.
One of the Department's tasks in revising Part 40 is to make appropriate adaptations to the altered shape of the drug and alcohol testing business. We have no desire to stand as King Canute before the marketplace sea. Nor do we wish to surrender to purely economic considerations features of the program we regard as critical to its integrity. The goal of finding an appropriate balance has influenced our efforts in a number of areas as part of this rulemaking, including the functions of MROs and SAPs and the issue of how test results are reported to employers.
In the NPRM, the Department proposed keeping sharp lines of demarcation between different participants in the program. Specifically, we proposed putting into regulatory text the interpretation we have maintained under the existing rule with respect to the transmission of drug test results from MROs to employers. That is, MROs must report the results directly to employers. C/TPAs could not act as intermediaries in this process. This position was based on the premise that indirect reporting was likely to be slower, and more prone to error and compromise of confidentiality, than direct reporting.
Comments
The bulk of comments on this issue came from TPAs, who asserted that they should be permitted to act as intermediaries in the transmission of drug testing results. There were also comments from employers and unions, most of which supported the TPAs' position. During discussions of this issue in the listening sessions, DOT staff asked TPAs to address the question of how it was as or more efficient and effective to move a result from Point A (the MRO) to point B (the employer) through Point C (a TPA), rather than sending it directly from Point A to Point B. Many of the C/TPA comments did address this question.
A common response was that many MROs do not have the staff or electronic capability to receive, process, and transmit results to clients. Indeed, many smaller doctors' offices would find it burdensome to handle all the paperwork. It is more efficient division of labor to have doctors concentrating on medical review and TPAs on information distribution, some said. TPAs, commenters said, are set up to act as electronic transfer points for data, allowing for the more efficient and timely delivery of results. Requiring the MRO to transmit the results directly would increase rather than decrease processing time and add costs.
Commenters favoring change in this proposal also said that TPAs know the rules and regulations well, since this is their full-time business. Small employers find it easier to call one place - the TPA - for all drug program information rather than having to deal with a variety of sources. Some of these commenters noted that, in the Coast Guard program, TPAs had played this role successfully for some time. They said there was no evidence of any detriment to public safety in this case, or in other cases where TPAs (contrary to existing rules) have transmitted results.
Some MROs and TPAs disagreed with this point of view, citing concerns about delays, administrative errors, and risks to confidentiality. Commenters said that many MROs are fully capable of transmitting results information directly to employers, and that if an employer found that it was not receiving results in a timely fashion, it could change MROs. In addition, direct MRO transmission may provide greater value to employers, because MROs can answer questions about the result and help the employer resolve procedural issues.
Comment on this issue focused on MRO transmission of verified drug testing results to employers. However, many commenters mentioned other areas in which similar issues arise, such as laboratory transmission of results to MROs, transmission of SAP reports to employers, and transmission of alcohol test results from BATs to employers.
A related, but distinct, issue concerned who could appropriately play the role of the designated employer representative (DER). Some commenters said that C/TPAs should be able to act for employers as DERs, at least in small companies. Some of these comments alleged that the role of the DER was a complex, multifaceted one, and that it would be very costly, particularly for small companies, to hire a DER.
DOT Response
The Department is persuaded by the comments on this subject that C/TPAs have the ability to transmit verified drug test results to employers as or more efficiently than MROs who transmit the information directly. While we understand, and to an extent share, concerns about potential delays, errors, and breaches of confidentiality when intermediaries are used, we do not have any evidence in the record that these problems actually occur in any significant way. The Coast Guard experience, as reported by commenters (including some employer and union commenters) and verified by Coast Guard staff, suggests that the parties concerned in that industry are satisfied with this approach.
Consequently, the final rule (see §40.345) gives employers the choice of receiving drug test results directly from the MRO or via a C/TPA. We emphasize that it is up to the employer - not the C/TPA -- to make this choice. The employer can make this choice for any or all of the items listed in Appendix F (e.g., an employer may choose to receive some items via the TPA and others directly from an MRO). The rule authorizes C/TPAs to act as intermediaries in the transmittal of information to employers only with respect to the specific provisions of the rule listed in Appendix F. C/TPAs are prohibited from acting as an intermediary in transmitting information not listed in Appendix F.
For example, C/TPAs are not allowed to act as an intermediary who transmits laboratory test results to MROs , SAP reports to employers, or medical information from MROs to employers. In the case of the laboratory reports, we believe that the direct link between laboratories and MROs is critical to the timely and independent medical review of those results. (Certainly laboratories have the electronic capability to readily transmit results directly to MROs in a timely and accurate fashion.) With respect to SAP reports, we are concerned that using an intermediary creates the opportunity and temptation to alter the SAP's recommendations (a problem that DOT staff have noted in the current program). With respect to medical information, we believe this is confidential medical data that should not pass through an additional hand on its way from the MRO to the employer.
The discussion of this issue among commenters focused mainly, though not exclusively, on drug test information. A few commenters mentioned that similar considerations should apply to alcohol testing information. With respect to "negative" alcohol test results (i.e., results of less than 0.02), we agree. The same rationale that supports permitting drug testing information to be conveyed by C/TPAs applies to this information. However, we draw a distinction with respect to alcohol testing results of 0.02 or higher. These results - unlike positive drug test results or negative drug or alcohol test results - mean that an employee is, to some extent, impaired by alcohol. As a safety matter, the employer must immediately remove the employee from performance of safety-sensitive functions. This is a situation where time is of the essence, and we therefore will continue to require BATs to transmit these results directly to employers. C/TPAs are not authorized to act as an intermediary in this situation.
We believe that it is essential that someone employed by the actual transportation employer act as the DER. The DER's function is to receive information about certain kinds of test results and take required action, such as removing an employee from the performance of safety-sensitive functions. Someone who is an employee of a C/TPA, rather than of the actual transportation employer, is less well situated to perform these functions, especially since a C/TPA representative generally does not have line authority over a transportation employer's employees.
Much of the comment on this issue appears based on a significant misunderstanding of the role of a DER. A DER is not a drug and alcohol program manager. A DER does not need extensive knowledge about the DOT drug and alcohol testing program and need not spend extensive time on DER duties. The DER is simply someone who can act immediately to remove an employee from safety-sensitive functions, or take other appropriate action, upon receipt of information that the employee has violated the rules or needs to be subject to certain testing requirements. Particularly for small companies (e.g., a 3- 10 driver trucking company), the DER is likely to perform this function on a collateral duty basis, fielding a rare phone call (i.e., there are not many tests per year and only a small percentage of tests result in violations) and removing an employee from safety-sensitive functions on those occasions. This is not a time- or resources-intensive activity, and it would certainly not require hiring an extra human resources staff person.
The one exception the final rule makes concerns owner-operators. Under the FMCSA rule,
owner-operators are, in effect, required to get at least random testing services through a C/TPA. In an
owner-operator, the driver is his or her own boss, so there is no one else in his or her own organization
to direct him or her to stop performing safety-sensitive functions. In this situation, we think it is
probably better to permit the C/TPA to perform what otherwise would be a DER function.
Collection Process Issues
Commenters were interested in a variety of issues in the drug testing collection process. These included dilution issues, the consequences of refusing to drink fluids and the length of the interval before the second collection attempt in "shy bladder" situations, retests under direct observation when a split specimen is unavailable for testing, using split specimen collections in all DOT modes, and having employees remove boots as part of the preparation for a collection.
Comments
The first issue in this category is whether, when there is a specimen that is both negative and dilute, there should be an immediate recollection under direct observation. Commenters took a number of positions on the issue. Some employers and service agents favored making retests under direct observation mandatory, on the ground that a dilute specimen effectively formed a basis for a reasonable suspicion that the employee had tried to conceal drug use. Some unions and service agents opposed such a requirement because it would intrude on employees' privacy, might well result from innocent consumption of water, and was of dubious value in deterring and detecting illegal drug use.
A plurality of commenters favored making a recollection, as well as the decision about whether to use direct observation, optional with the employer. This approach, they said, would recognize the variety of situations in which a dilute specimen may occur. It could be done in consultation with MROs, to ensure that there was some medical input into the employer's decision.
The second, related issue is whether an employer should be able to disregard a negative dilute result. For example, suppose an employer receives such a result on an applicant's pre-employment test. Should the employer be able to require the applicant to take another test to get a "real negative" before beginning safety-sensitive work? Most employers, and some service agents, who commented on this issue favored this approach, especially in pre-employment testing. They did so in the belief that a negative dilute result was, at best, questionable. Even if it did not result from a deliberate attempt to cheat on a test, it was not as definite a demonstration of compliance as a negative test from a more concentrated specimen. Unions and some service agents disagreed, saying that this would unnecessarily burden employees, including many who could achieve dilute (as distinct from substituted) results naturally, by drinking a lot of water (which some commenters made a point of noting was a legal substance). This approach would involve a "guilty until proved innocent" approach, in this view.
Most, though not all, employers said that an employee who refuses to drink additional liquids after failing in his or her initial attempt to produce a sufficient specimen should be regarded as having refused to test. These commenters saw refusals to drink as attempts by employees who had used drugs to avoid a positive test. They also viewed it as a waste of up to three hours of time that the employee remained off the job (but presumably in paid status). Some service agents also shared this point of view. Unions and other service agents disagreed. They said that an employee could have legitimate health or other reasons for not wanting to drink additional fluids. Moreover, if an employee fails to drink fluids, and consequently fails to produce a sufficient specimen on the second try, the employee will be referred to a physician for an evaluation. If the physician does not find that a medical condition produced, or could have produced, the inability to provide a sufficient specimen, the employee will be treated as having refused the test. This consequence is sufficient, these commenters said.
When an employee has a verified positive test, the Omnibus Employee Testing Act gives the employee the right to request a test of the split specimen. The Department has long taken the position that if the employee makes a timely request to test the split specimen, and the split specimen is unavailable for testing (e.g., the split specimen was never collected, leaked away, or was lost), the test must be cancelled. While we believe this outcome is necessary as a matter of law, it raises a safety concern. In such cases, we have an apparently valid, verified positive result, indicating that the employee used illegal drugs. However, because of the accidental unavailability of the split specimen, the employee can continue to perform safety-sensitive functions.
In response to this concern, the NPRM sought comment on the idea of requiring a recollection under direct observation in these cases. This might detect drug use by the employee and result in his or her removal from the performance of safety-sensitive functions. The rationale for the direct observation aspect of the procedure reflects the belief that an employee, having recently tested positive, may have an additional incentive to cheat on the second test.
Comment was divided on this issue. Employers generally supported the proposal to require recollection under direct observation on the safety rationale mentioned above. Unions and some service agents opposed the proposal, saying that it undermined the employee's right to a test of the split specimen. Some added that the second test would not really answer the question of whether the employee has tested positive on the first test. Opponents of the proposal particularly objected to the direct observation aspect of it, on intrusiveness and violation of privacy grounds. Why, they asked, should someone suffer a directly observed test because the collector made an error?
Currently, those DOT agencies covered by the Omnibus Transportation Employee Testing Act - FRA, FAA, FTA, and FMCSA - are required to collect split specimens. RSPA and Coast Guard, whom the Act does not cover, give employers the choice of collecting single or split specimens. Commenters on this point almost unanimously favored requiring split specimens in all DOT agency programs. They said that this would be much simpler and less confusing, and likely would reduce the incidence of errors (e.g., failure to collect split specimens where required). Split specimen collections are not any more expensive than single specimens, one commenter said. One commenter questioned the Department's authority to require split specimen testing in RSPA and the Coast Guard absent legislation.
The Department has heard concerns, over the years, that some employees have concealed adulterants or other means of tampering with tests in their boots (e.g., cowboy boots). For this reason, the NPRM proposed that collectors would ask employees to remove their boots, so that collectors could check them for such items. Commenters almost unanimously panned this proposal, asserting that it was intrusive, ineffective, and inconsistent (i.e., vis a vis the rule's treatment of other footwear and clothing). Commenters raised specters ranging from confrontations between employees and collectors to exposing collectors to unpleasant foot odors.
DOT Response
With respect to the issue of negative dilute tests, the Department has decided to give employers discretion about how to handle these situations (see §40.197). There are reasonable arguments on both sides of this question, and the Department is not persuaded that that there is a single, across-the-board, right answer. The variety of circumstances among employers appears too wide to permit a unitary solution. In response to concerns about recollections being unduly burdensome on employees, the Department will require that a given employer treat all employees equally, to avoid the possibility of arbitrary selections of individuals for recollection. That is, an employer would have to treat all situations in a given category the same way (e.g., require recollections in all pre-employment test situations that had negative dilute results). This would prevent employers from singling out disfavored employees. In addition, employers would be limited to a total of two tests (the original negative dilute result and one recollection). They could not conduct additional tests if the recollection were also a negative dilute, for example. This provision limits the potential burden on employees.
If an employer chooses to conduct another test, it could not be conducted under direct observation, unless one of the other circumstances permitting or requiring direct observation occurred. We use direct observation primarily to counter the likelihood of tampering at the collection site. This makes sense in situations where we are mostly concerned about adulteration or substitution. Most dilution cases, however, arise because an individual hydrates his or her system before going to the collection site. Privacy issues aside, then, direct observation seems off point in the dilution situation. What is useful is giving an employee the shortest possible interval between notice of the test and the conduct of the test, so that the individual does not have time to overhydrate. For this reason, the rule requires employers to provide no advance notice of the recollection to employees.
The Department will not include any general provision requiring or authorizing employers to disregard the results of negative dilute tests. Given the structure of the rule, such a provision is unnecessary. Employers have the discretion to conduct one recollection following a negative dilute result. If the employer chooses not to conduct a recollection, then the negative result is the only result it has, and the employer will rely on the result just as is does in any other case. If the employer does conduct a recollection, then the result of the recollection - not the original test - becomes the result on which the employer relies for all purposes. The original test would be cancelled in this situation, and not reported for management information system (MIS) purposes.
The bottom line in any "shy bladder" situation is that, if, by the end of the collection process, the employee has not produced a sufficient specimen, the employee must be evaluated by a physician. Unless the physician finds that a medical condition resulted, or could have resulted, in the inability to provide a sufficient specimen, the employee is regarded as having refused to test (see §40.193). Given this provision, we believe it is unnecessary to say that a refusal to drink fluids, standing alone, is a refusal to test.
As some commenters said, there may be legitimate reasons for an employee's decision not to drink fluids in this situation. In any case, if the employee declines to drink, subsequently does not produce a sufficient specimen, and cannot establish a medical condition explaining his or her inability to provide the specimen, a refusal to test will be established. While having employees waiting in a collection site for three hours, with or without drinking, may annoy employers and collectors, we do not believe this is a sufficient reason to terminate the shy bladder process because the employee does not choose to drink during that period.
We believe that there is a strong safety rationale for requiring a recollection under direct observation following a verified positive, adulterated, or substituted test that is cancelled because the split specimen is unavailable for testing. In this situation, we know that there were drugs or an adulterant in, or substitution of, the primary specimen, and that there was no legitimate medical explanation. Split specimens fail to reconfirm the result of the test of the primary specimen in only a tiny minority of cases. If we do not collect another specimen in this case, there is a very high probability that we will be permitting an employee who has used illegal drugs, or tried to tamper with a test, to continue performing safety-sensitive functions. That is a significant safety concern.
By recollecting another specimen, we have some possibility of detecting continuing drug use. Knowing that recollections will occur in this situation may also have some deterrent effect on employees. By recollecting another specimen under direct observation, we can limit the opportunities for tampering, for which there is a heightened incentive in this situation. We do not view this provision as penalizing an employee because a laboratory or collector erred. Rather, in the face of a laboratory or collector error, we view this provision as closing an inappropriate loophole for an employee who appears to have used illegal drugs or tried to defeat a test.
We agree with commenters that it makes much more sense for all DOT agencies to have consistent requirements concerning split specimens. Therefore, Part 40 requires all collections to be split specimen collections, and RSPA and Coast Guard will amend their rules accordingly. We will delete from Part 40 all references to single specimen collections. There is no legal authority issue here: RSPA and Coast Guard base their rules on their statutory general safety authority, which does not contain specific requirements or prohibitions concerning how drug specimens are collected. There is no legal difference between these agencies using their discretion in implementing their general safety authorities by requiring split specimen testing and using it to give employers an option between split specimen or single specimen collections.
We are persuaded by commenters that we should not go forward with the proposal to have collectors
remove and inspect boots. The problems of this approach likely outweigh the benefits. Therefore, we
have booted this provision out of the final rule.
Information Release Issues
MROs sometimes find themselves in a dilemma. They verify a positive test result on an employee of Employer A. They also know that the same employee works in a DOT-regulated safety-sensitive position for Employer B. Consistent with safety and confidentiality responsibilities, what should the MRO do? The NPRM sought comment on this issue. The NPRM also asked for comment on whether MROs and other parties (e.g., C/TPAs) should report positive tests and other rule violations to DOT operating agencies, so that they could take enforcement action.
Comments
There was a variety of comment on the idea of MROs sharing test information with other employers. Many employers, MROs, unions and other parties opposed allowing MROs to do so because it would breach employee confidentiality. Given the large data bases that some service agents maintain, this breach could be very wide, some commenters said. Some service agents questioned whether the proposed rule's language would have the effect of creating a duty on service agents to conduct searches of such data bases.
Other MROs and employers favored giving MROs this discretion, in order to enhance safety and help MROs who find themselves in this dilemma. Commenters cited potential liability concerns on both sides of the question. Other commenters suggested that more systematic approaches to this problem might be more productive, such as creating a national data base of persons who had violated rules or requiring employers hiring new workers to check with previous employers about past test results (as FMCSA's rule already does). Canadian commenters also mentioned a concern that information release to third parties without individual employee consent may violate Canadian law.
Commenters addressed the issue of release of information in legal proceedings. The existing rule and the NPRM focus on legal proceedings brought by an employee (e.g., an unjust termination suit). What about personal injury cases in which the employee's test result is a relevant issue, commenters asked.
Some commenters thought that having service agents report rule violations to the DOT agencies was a good idea that would enhance safety. For example, if an owner-operator fails to show up for a test and continues to drive, only the C/TPA may know of the refusal. If the C/TPA does not report the problem to FMCSA, the likelihood of the owner-operator getting away with his or her refusal is heightened. Others raised confidentiality concerns and thought that there could be problems if service agents reported incomplete or erroneous information to the DOT agencies. Some service agents also feared that if they had authority to report violations to DOT agencies, even if this were not mandatory under the rule, they would be liable for not doing so. Others thought that this would create a difficult conflict of interest situation for service agents.
DOT Response
The Department has decided to drop the proposal to permit or require MROs to pass on to third party employers information about the results of tests the employee took at the direction of another employer. The Department understands that confidentiality rules sometimes place MROs in a difficult position. Nevertheless, confidentiality is a cornerstone of the balance between safety and employee privacy that is crucial to the acceptance and constitutionality of the testing program. The Department is also concerned that it would be very difficult to draft a provision that solved the "doctor's dilemma" situation without opening the floodgates to widespread searching of large data bases for information on employee testing records that could severely compromise confidentiality. We do not think our NPRM language succeeded at this task. Consequently, as under the current rule, MROs will be prohibited from passing such information on to third party employers without the employee's consent. As described in the discussion of §40.25, we are adding a requirement to query previous employers for drug and alcohol test information in place of the proposed provision, based on an existing FMCSA provision.
Another alternative to the proposal would be to create a Federal data base that would include all test results, which authorized employers could search to learn authorized information about current or prospective employees. This is a significant issue, but not one we are able to resolve at this time. We do believe that, in order to be effective, a data base of this sort would have to be national in scope under Federal supervision, rather than a mixture of state, local, and private data bases. It would also have to successfully solve security, access, due process, and updating issues. Creation of such a data base remains a matter for further study.
The Department has decided to broaden the scope of release of information in the context of legal proceedings. We have added a provision (see §40.323) that would permit employers to release test information in a criminal or civil court proceeding resulting from an employee's performance of safety-sensitive duties, if the court orders it. For example, in personal injury litigation following a truck or bus collision, the court could determine that a post-accident drug test result of an employee is relevant to determining whether the driver or the driver's employer was negligent. The employer would be authorized to respond to the court's order to produce the records.
There would be limits on the use of this information, however. The employer could release the information only to the decisionmaker, such as the judge in a lawsuit. It could be released only subject to a binding stipulation or protective order that the decisionmaker to whom it is released will make it available only to the parties to the proceeding, who could not disseminate it further or use it for other purposes. The Department believes that this approach provides for relevant use of test information without permitting the information to be spread about too widely. These limits also apply in situations where the information is made available in a proceeding brought by the employee (e.g., a grievance, arbitration, or lawsuit concerning personnel action following a violation).
The Department has decided against requiring service agents to report apparent violations of the rules
to the DOT agencies. Service agents can do so in any situation in which DOT agency rules already
permit them to do so. The principal reason for this decision is that the Department's enforcement
resources are limited. The DOT agencies must take great care in prioritizing the use of those resources,
so that the greatest safety benefit is derived from their allocation.
Service Agent Contract Language
The NPRM proposed that every contract or agreement between an employer and a service agent would have to include an assurance of compliance with DOT rules. The purpose of this proposal was to ensure that the obligation to comply with Part 40 and other DOT rules was not only a matter of regulation, but also a key part of the contractual relationship among participants in the testing program.
Comments
Some employers and unions favored the proposed requirement, saying that it would help them ensure that services were provided properly. They said it would create universally understood contract remedies if service agents failed to provide appropriate services. Most of the commenters on this proposal were service agents, and they almost unanimously opposed the proposal. They said it would add substantially to the paperwork burden of the rule and would add costs (e.g., for attorney involvement in the contracting process). Moreover, opponents said, there are many times in which employers do not have written contracts with some service agents (e.g., collection sites remote from the employer's principal place of business), so there is no contract in which to incorporate such a clause. Requiring written contracts where none now exist would also be unnecessarily burdensome, they said. A mandatory contract clause could also lead to litigation, some commenters feared.
DOT Response
The purpose of the proposed requirement was to ensure that compliance by service agents with this and
other DOT rules was an enforceable contractual responsibility. The Department now believes that this
purpose can be achieved by other means. We have replaced the proposed written contract clause
requirement with a regulatory statement (see §40.11(c)). It provides that all agreements and
arrangements, written or unwritten, between employers and service agents are deemed, as a matter of
law, to require compliance with all applicable provisions of this part and DOT agency drug and alcohol
testing regulations. The rule declares that compliance with these provisions is a material term of all such
agreements and arrangements. Combined with the PIE provisions of Subpart R, this provision ensures
that when a service agent is in noncompliance, DOT (through a PIE) or an employer (through a contract
action) can respond effectively to service agent noncompliance. These provisions will achieve the
Department's objective without incurring the paperwork burden and other problems cited by
commenters with the NPRM provision. We also did not want to create potential compliance problems
for service agents and employers based on the lack of a written agreement.
Electronic Technology Applications
The NPRM asked for comment on how best to incorporate electronic technology into the drug and alcohol testing process to a greater extent.
Comments
A substantial majority of all commenters on this issue strongly supported the wider use of electronic technology throughout the DOT drug and alcohol testing program. The suggested applications included such things as electronic signatures by various participants, an electronic CCF, and electronic storage and transmission of data. One of the goals mentioned in some comments was the "paperless lab." Supporters emphasized the greater speed and efficiency of these applications, contrasted to a paper-based system. Some commenters noted that electronic applications of this kind were already in wide use in the private, non-regulated sector of drug and alcohol testing, and that the Food and Drug Administration had approved the use of electronic signatures in some contexts.
Commenters mentioned that, in order to do the job right, electronic applications had to ensure the integrity and security of information, but many commenters also said that appropriate technological tools for this purpose already existed. Some commenters sounded cautionary notes, particularly with respect to the Department being assured of the effectiveness of system safeguards and the forensic acceptability of electronic records and signatures before authorizing additional use of electronic applications in the program.
DOT Response
The Department believes that the increased use of electronic methods in the program is both inevitable and beneficial. At the same time, we want to make sure that there are good, consistent minimum standards for the use of this technology, so that the integrity and confidentiality requirements of the program continue to be met. For this reason, the Department, in cooperation with HHS and the Office and Management and Budget (OMB), intend to form an advisory committee under the Federal Advisory Committee Act. Many of the interested parties began meeting this past summer to discuss the issues under the auspices of an OMB information technology initiative.
This committee would be charged with making recommendations to DOT and HHS concerning changes in our regulations we could make to accommodate electronic technology. The committee would also make recommendations about consistent minimum standards for the technology used in Federal drug and alcohol testing programs. The Department anticipates that, following the receipt of the committee's recommendations, DOT and HHS will propose changes to Part 40 and the HHS Guidelines that will result in authorizing the more widespread use of electronic technology in the program.
Meanwhile, the Department will make some modest changes to its requirements. For example, we will
permit greater use of faxes and scanned computer images for reporting test results. Additionally, we are
permitting laboratories to send electronic results reports to the MROs, provided that the laboratory and
the MRO ensure that the information is accurate and can be transmitted in such a manner as to prevent
unauthorized access or release of this information while it is transmitted or stored. The Department, at
this point, is not requiring specific transmission or security standards, but as these are developed in the
future, we will provide them as guidance for laboratories and MROs. Even when the Department has
changed its regulations to permit greater use of electronic methods, we expect to retain the option to use
a paper-based system, however. This is because many of the participants in our program, such as small
transportation employers, may not be equipped to participate in a fully electronic system.
MRO/Laboratory Conflicts of Interest
The Department has long believed that the MRO has a uniquely important responsibility for maintaining the integrity of the Department's drug testing system. For that reason, since the beginning of the Department's program, we have been concerned about the potential of conflicts of interest between MROs and other participants in the system, particularly the laboratory. For example, if an MRO is reviewing results of a laboratory with which the MRO has a financial relationship, it could happen, or appear to happen, that the MRO would be less likely to bring problems in the laboratory's test results to light. In the NPRM, the Department asked commenters for their thoughts on conflicts of interest, particularly whether the Department should state with greater specificity the kinds of relationship that involve conflicts or the appearance of conflicts.
Comments
Some commenters questioned the NPRM's focus on the MRO-laboratory relationship, saying there were other relationships among participants that could be as or more troubling (e.g., laboratory-collection site relationships). Commenters also differed about what the rule should say about laboratory-MRO relationships. Some commenters favored a strict separation of roles, while others said that the program would be more efficient and less costly if MROs and laboratories could collaborate more closely. Some commenters, in response to a preamble question, supported adding more specific guidance to the rule on what sorts of relationships were considered inappropriate.
A large majority of comments on this issue said it was important for the rule text to list the kinds of relationships that the Department regarded as creating conflicts of interest between MROs and laboratories. The comments acknowledged the significance of maintaining laboratory/MRO relationships that were free of such conflicts, in order to maintain the integrity of the program. In the absence of specificity, however, a general provision prohibiting conflicts or requiring a certification that there were none would be ineffective, they said. Commenters generally agreed with the list of conflicts listed in the NPRM preamble, as a means of ensuring the necessary separation of functions among participants. Commenters who dissented from this position usually argued that to prohibit close MRO/laboratory relationships would interfere with the integrated organizational arrangements that were most efficient in providing services to customers economically (e.g., one-stop shopping or "turnkey" programs).
. DOT Response
We agree that other relationships in the program might create conflict of interest issues. However, we continue to believe that the focus on the MRO-laboratory relationship is appropriate. In our view, the MRO is a key participant in the process, whose role is to be the most important protector of the accuracy and integrity of the process. A potential conflict of interest between an MRO and a laboratory, whose results the MRO must review, oversee, and, if necessary, question, is a particularly sensitive matter for the integrity of the program. We urge appropriate caution, use of firewalls, etc. to avoid potential conflicts of interest among all participants, but we believe that clear regulatory guidance is important in the MRO/laboratory relationship.
While we recognize that commenters' views differ, we believe the program is best served by avoiding MRO/laboratory conflicts of interest or their appearance. We believe that a clear separation of their respective roles is necessary for this purpose. We have maintained this separation under the current rule, and we do not have evidence that this has unduly hampered the efficiency of the program.
In response to comments, we have added list of actions that we view as creating the reality or appearance of a conflict of interest. These examples are not new creations: they codify guidance that the Department has given in several specific situations over the years. They are essentially the same examples listed in the preamble to the NPRM, with the clarification that they apply to MROs who actually review test results produced by the laboratory in question. This list of examples is not exclusive or exhaustive: other situations may arise that would constitute conflicts. The list is the following:
(1) The laboratory employs an MRO who reviews test results
produced by the laboratory.
(2) The laboratory has a contract or retainer with the MRO for the review of test results produced by the laboratory.
(3) The laboratory designates which MRO the employer is to use, recommends certain MROs, or gives the employer a slate of MROs from which to choose. We do not interpret this provision to prohibit laboratories from referring employers to a large, global list of MROs (e.g., a list of all MROs who have been certified by one of the national MRO training organizations), so long as the laboratory does not edit the list or express a preference or recommendation among the MROs on the list.
(4) The laboratory gives the employer a discount or other incentive to use a particular MRO.
(5) The laboratory has its place of business co-located with that of an MRO or MRO staff who review test results produced by the laboratory;
(6) The laboratory derives a financial or other benefit from having an employer use a particular MRO; or
(7) The laboratory permits an MRO, or an MRO's organization, to have a significant financial interest
in the laboratory.
Validity Testing
By validity testing, we mean testing that laboratories conduct to deter and detect tampering with tests. The two most important categories of tampering are adulterating a specimen (e.g., putting a substance into a specimen designed to mask or destroy the drug or drug metabolite that the specimen may contain) or substituting a specimen (e.g., supplying water or some other substance in place of urine). The NPRM proposed to require laboratories to conduct validity testing on all specimens. It asked for comment on whether MRO review and split specimen testing should be applied to specimens that laboratories found to be adulterated or substituted, as they are to specimens that test positive for drugs. Validity testing is probably the most difficult and controversial issue in this rulemaking.
Comments
1. Adulteration
A significant majority of commenters on the subject supported the idea of testing for adulterants. Commenters said that the purpose of such testing was to counteract tampering, which some said appeared to be on the rise in their experience. They cited the increased availability of substances and techniques claiming to protect drug users from testing positive for drugs, which are quite commonly advertised in publications and on the internet.
Many commenters cited the volatility of the adulterant market, noting that the popularity of particular adulterants rise and fall. As countermeasures to one substance are found, other adulterants come into prominence, in a continuing "arms race" between those who try to facilitate and those who try to deter and detect ways of "beating the test. " Therefore, commenters said, there needs to be flexibility in the "adulteration panels" that laboratories use, to allow them to keep up with an ever-changing adulterant market. It is not helpful, in view of this need for flexibility, to mandate testing for specific substances such as nitrites, several commenters said.
Two employee groups said that there was no evidence supporting the need for adulterant testing. They also said that adulterant testing was too burdensome. One laboratory suggested that adulterant testing should remain discretionary with laboratories, rather than mandated by the rule. Another commenter said that there should be standardized DHHS testing methodologies for adulterants, just as there are for drugs. Several commenters supported extending the blind testing program to adulterated and substituted specimens as a further safeguard. A few commenters addressed the issue of cost, but they did not agree with one another about whether adulterant testing would add significant costs to the program. Supporters of alternative testing methods (e.g., saliva, hair, on-site testing) argued that their methods would be quicker and more effective at detecting adulterants than the present laboratory-based urine testing system.
2. Substitution
Generally, commenters who supported testing for adulteration also supported testing for substitution. However, a number of commenters had greater concerns about substitution testing. Some comments, including one extensive comment submitted by a union, contended that the criteria for substitution developed by HHS, and incorporated in the NPRM, were faulty and based on inadequate studies. In particular, this comment criticized the HHS criteria because the literature on which the specific gravity and creatinine levels had been based included very few "paired studies" looking at both criteria at once. Other comments criticized the studies because they had not specifically covered certain employee subgroups. A few comments suggested changing the name of this sort of specimen from "substituted," which they found too conclusory, to "hyper-dilute" or something similar, which they believed to be more neutral and descriptive.
During the listening sessions and in written comments, a number of individuals said they, or people they know, had been unfairly terminated on the basis of substitution. These individuals were not drug users, they said, but had consumed large quantities of water over a long work period. In addition, they were often small-framed minority women, vegetarians in some cases. They suggested that a combination of these circumstances could have resulted in the natural, innocent production of urine meeting the substitution criteria. They sought additional procedural protections and revision of the substitution criteria to prevent people from being unfairly found to have substituted a specimen.
3. Split Specimen Testing
The Department presen