49 CFR Part 40 – DOT Procedures (continued)

Subpart H – Split Specimen Tests

§40.171 How does an employee request a test of a split specimen?
There were few comments on this section. A number of commenters wanted to require that requests for tests of split specimens be in writing. One reason given for this request was that some employees, if the split specimen test reconfirmed, would deny asking for the test when the employer asked for reimbursement. We do not think it necessary to require these requests to be in writing, which in some instances could delay or burden the employee’s right to have the split specimen retested. However, so that there is a written record of the request, the NPRM and this final rule direct MROs to document the date and time of the employee’s request.

§40.173 Who is responsible for paying for the test of a split specimen?
This section is related to the provision concerning payment for split specimen tests in §40.153, and commenters took very similar positions on the issues. Not surprisingly, unions and some service agents liked the proposal better than employers. The Department’s rationale for incorporating this provision in the final rule is essentially the same as discussed under §40.153 above. Employers did want assurance that they could seek reimbursement from employees, and paragraph (c) of both the NPRM and final rule makes that point clear. We added an example of how employers could ensure that testing occurs on time (establishing accounts with laboratories, which they could do on their own or through a C/TPA).

§40.175 What steps does the first laboratory take with a split specimen?
There were few comments concerning this section. Some commenters asked that tests be cancelled when a split specimen was unavailable. For reasons discussed above, the Department believes it is better to test the primary specimen in such cases. Some commenters addressed proposed §40.175(c), which we have deleted because it duplicated laboratory procedure matters in HHS guidance. Laboratories will follow this HHS guidance with respect to specimen retention requirements. Commenters asked for clarification of who gets to choose the laboratory that tests the split specimen. This is an issue on which the Department does not have a position. We are satisfied as long as the parties use an HHS-certified laboratory.

§40.177 What does the second laboratory do with the split specimen when it is being tested to reconfirm the presence of a drug or drug metabolite?
§40.179 What does the second laboratory do with the split specimen when it is being tested to reconfirm an adulterated test result?
§40.181 What does the second laboratory do with the split specimen when it is being tested to reconfirm a substituted test result?
These sections are all based on proposed §40.177. Most of the comments on proposed §40.177 concerned the addition of validity testing to the split specimen portion of the program, discussed in greater detail in the “Primary Policy Issues” portion of the preamble.
Existing HHS guidance (Program Documents 35 and 37) establish criteria for testing of the primary specimen for adulteration and substitution. These are the criteria referenced in §§40.93 and 40.95. These Program Documents do not, on their face, apply to testing of the split specimen. HHS is planning to incorporate split specimen testing criteria for adulteration in forthcoming mandatory requirements for validity testing. Pending completion of this formal HHS issuance, and because we believe it is important to begin split specimen testing in the validity testing program as soon as possible, the Department in §§40.179 and 40.181 is requiring that the split specimen meet exactly the same criteria as the primary specimen in order to be considered reconfirmed. These criteria already exist in HHS guidance (Program Documents 35 and 37) and have a sound technical basis. When HHS issues its final mandatory requirements for split specimen tests in adulteration and substitution cases, the Department will, if necessary, amending amend these provisions to refer to the HHS issuance.

§40.183 What information do laboratories report to MROs regarding split specimen results?
This section is based on proposed §40.181 of the NPRM. There were no substantive comments. We have adopted the section as proposed, except that we have added notations applicable to split specimen tests in adulteration and substitution situations. We also clarified that laboratories must sign and date the appropriate CCF copy.

§40.185 Through what methods and to whom must a laboratory transmit split specimen results?
This section is based on proposed §40.179 of the NPRM. Comments focused on two issues: the use of electronic means of transmission and use of service agents as intermediaries between laboratories and MROs. In response to comments favoring greater use of electronic means, the final rule will permit results to be sent by electronic image, as well as other means. However, for the same reasons applicable to transmission of primary specimen test results, we will not permit C/TPAs to receive split specimen results from laboratories.. Laboratories must promptly send split specimen results directly to MROs.

§40.187 What does the MRO do with split specimen laboratory results?
This section is based on proposed §40.183 of the NPRM. Some commenters objected to a retest under direct observation as the consequence of a failure to reconfirm due to the unavailability of the split specimen for testing. As noted above, this situation involves strong evidence of a violation of the rules (e.g., a verified positive test), with the test being cancelled only because of a process problem (e.g., the split leaked away). In this situation, there is a stronger than usual incentive for the employee to attempt to beat the next test, hence the need for direct observation on the recollection.
The Department deleted proposed section§40.185, concerning retests of single specimen collections, since all collections under the new rule will be split specimen collections.

§40.189 Where is other information concerning split specimens found in this regulation?
This is another in the series of cross-reference sections designed to help readers find related material.

Subpart I – Problems in Drug Tests
§40.191 What is a refusal to take a DOT drug test, and what are the consequences?
If an employee declines to take a drug test or takes a number of other actions that obstruct the drug testing process, the employee is deemed to have refused to test. For the most part, the consequences of a refusal are the same or more severe as for any other violation of DOT agency drug and alcohol regulations.
Commenters generally agreed with the list of actions in this section that constitute a refusal to test. One commenter wanted refusals on non-DOT tests to count as refusals under this part. They cannot, because this part does not require anyone to take a non-DOT test. A few comments also urged use of alternative testing technologies, such hair testing and on-site testing, in potential refusal situations. The Department will defer to HHS on alternative testing technology issues. HHS has not yet authorized these approaches to testing. We have added a specific reference to verified adulterated or substituted test results as a ground for determining that an employee has refused to test.

§40.193 What happens when an employee does not provide a sufficient amount of urine for a drug test?
This is the so-called “shy bladder” provision of the rule. The proposed section would keep the core of the Department’s current shy bladder procedures in place, and commenters did not question the direction of this provision. Commenters did address a number of specific issues concerning the section. Some commenters wanted to specify that the physician performing an evaluation of potential medical reasons for a shy bladder situation be a urologist or other specialist, on the theory that a non-specialist was not as well equipped for this function. The Department agrees, and, in parallel with the language concerning MRO review of adulteration and substitution provisions, the final rule calls for the use of a licensed physician with expertise in the medical issues surrounding a failure to provide a sufficient specimen.
Commenters disagreed about who ought to select the physician for this evaluation. Some said the referral physician should be acceptable to the employer. Others said the referral physician should be acceptable to the employee. We take the view that the rule should not specify who makes the selection of the referral physician, but we do think that he or she should be acceptable to the MRO. The MRO is in a better position than either the employee or the employer to determine if a particular referral physician is appropriate to this task.
Under the final rule, the an employee in a shy bladder situation would be directed to obtain within 5 days, a further medical evaluation from someone with expertise in the medical issues raised by the employee’s situation. This physician could be a specialist (e.g., a urologist), but need not be. What is important is that the referral physician have sufficient expertise to deal effectively with the medical issues in the employee’s case.
The Department is aware that, in some cases, it may be difficult for an employee to secure, on his or her own, an appointment for this evaluation in a short period of time. Consequently, the Department does not regard it as a refusal to test if the employee is unable, after making good faith efforts, to get the appointment within the 5-day period. However, the MRO and the employer should do everything feasible to assist the employee in finding and getting an appointment with an appropriate referral physician.
Commenters raised in this context the issue of whether a refusal to drink fluids in a shy bladder situation should constitute a refusal to test. We do not believe that a refusal to drink fluids should be considered a refusal to test, and we have incorporated this view into the text of this section.
Some commenters suggested that, during the five days that may elapse between an employee’s provision of an insufficient specimen and the determination of whether this constitutes a refusal to test, the employee should be stood down from performing safety-sensitive functions. We are not adopting this suggestion. Until and unless a refusal is determined to have occurred, there is no evidence of violation of the rules on which to base a temporary removal from performance of safety-sensitive duties (unlike the situation under a stand-down waiver, where there is the evidence of a confirmed positive test).
A few comments questioned the three-hour waiting/fluid consumption period following an employee’s provision of an insufficient specimen. One comment said blood should be drawn after two hours. Other comments said it made more sense to go immediately to an alternative specimen, such as saliva or hair. We believe that the three-hour period is by now well established in the DOT program, and comments did not make a compelling case for changing it. As noted above, we are waiting for HHS action before making any further decisions concerning alternative specimens.
We incorporated in this section an existing DOT interpretation concerning psychological conditions alleged as reasons for a failure to provide a sufficient specimen. The meaning of this interpretation (see paragraph (e)) is that to be regarded as a pre-existing psychological disorder, it is not necessary that the condition be diagnosed before the time of the test, but the symptoms have to have been medically documented before the time of the test. For example, an individual may have brought urination problems to the attention of his urologist over a period of time, but the urologist did not enter a specific diagnosis of a psychological disorder into the medical records. In this situation, the examining physician has the discretion to determine that there was a pre-existing psychological condition, if the physician is convinced that the medically documented symptoms support such a diagnosis.

§40.195 What happens when an individual is unable to provide a sufficient amount of urine for a pre-employment or return-to-duty drug test because of a permanent or long-term medical condition?
This section is intended to address a rare, but difficult, issue that may arise in these types of testing. In a pre-employment or return-to-duty test, an employee who is not now performing safety-sensitive duties must have a negative test result in order to begin or resume performing safety-sensitive duties. In a “shy bladder” situation, if there is an adequate medical reason for the inability to provide a sufficient specimen, the test result is cancelled, not negative. If a permanent or long-term medical condition is the cause of the inability to provide a sufficient specimen, the employee might never be physically capable of obtaining a negative result. This could be very unfair to the employee, and it could raise Americans with Disabilities Act issues as well.
Some commenters expressed the view that this provision should apply to other types of testing as well (e.g., random). We do not believe it is necessary to do so, because employees in these situations do not need a negative test result to perform safety-sensitive functions. A cancelled test is not a violation of DOT rules that compels employers to remove employees from safety-sensitive duties.
In response to a comment, we added language that the MRO can conduct, or cause to be conducted, the further medical evaluation the section requires. We have also clarified that, as part of this evaluation, the physician may use alternative testing methods, including but not limited to blood testing, to help determine whether the employee shows clinical evidence of drug abuse. Particularly given that we do not apply this procedure to random testing, we do not agree with a suggestion that an individual covered by this section should be taken out of the random testing pool. Doing so would also affect the probability that other individuals would be selected for testing. As in other situations calling for medical evaluations, the rule requires that the physician conducting the evaluation be acceptable to the MRO, rather than to the employer or employee.
Under this section and §40.193, the referral physician reports to the MRO the basis for any conclusion that the individual has a permanent, long-term disability that prevents providing a sufficient specimen. However, for privacy reasons, neither the referral physician or the MRO passes on to the employer any information about the nature of the disability. The employer is simply told that there is a permanent, long-term condition.
We have not included similar language in the rule concerning alcohol testing, because pre-employment alcohol testing is not mandatory. In the rare situation in which an employee is required to have a negative alcohol test in a return-to-duty or follow-up test situation, and could not produce sufficient breath because of a permanent, long-term disability, we would apply the reasoning of this section to that situation.

§40.197 What happens when an employer receives a report of a dilute specimen?
This section is based on §§40.147(a) and 40.159(d) of the NPRM. The NPRM, like the existing rule, would have given employers discretion to use direct observation the next time the employee was selected for testing (e.g., in random testing). Comments on this issue and the Department’s responses are discussed under “Collection Issues” in the “Principal Policy Issues” portion of this preamble. It should be noted that, unlike the existing rule and the NPRM, this provision authorizes a new collection immediately following a negative-dilute result, rather than on the next occasion when an employee is selected for testing. This recollection is not conducted under direct observation.

§40.199 What problems always cause a drug test to be cancelled?
This section, listing “fatal flaws” that invariably result in the cancellation of a test, is based on §40.197 of the NPRM. The list of fatal flaws in the final rule is somewhat different from that in the proposed rule. Proposed paragraph (b), concerning the lack of a specimen ID number, is really an instance of the flaw cited in paragraph (a), a mismatch between the specimen ID numbers on the specimen bottle and the CCF. The former is included in the latter, so we have deleted the proposed paragraph (b). Consistent with HHS guidelines, we have added a new paragraph (b), concerning a situation in which the printed collector’s name and collector’s signature are both missing. This section’s list of fatal flaws is now consistent with the HHS list of fatal flaws.
A few comments suggested either that fatal flaws automatically cancel a test, without MRO involvement, or that the employer have the authority to cancel a test when a fatal flaw appears. We believe that, as the key “gatekeeper” and quality control person in the system, the MRO is the best party to make the actual pronouncement of a cancellation based on a fatal flaw. Another comment suggested that an error in the chain of custody documentation should result in the cancellation of a test. The problem here is that not all errors are created equal. Depending on the seriousness of an error and our ability to fix it, an error on the CCF can be a fatal flaw, a correctable flaw, or a de minimis error that does not result in cancellation.
Finally, a commenter asked whether Bottle B may be redesignated as Bottle A, as the final paragraph of this section suggests. This has been an interpretation issue under the existing rule, but we are clear in this final rule that such redesignations can take place.

§40.201 What problems always cause a drug test to be cancelled and may result in a requirement for another collection?
This section is based on §40.199 of the NRPM. One commenter suggested treating invalid test results as refusals. As we have discussed above, the Department did not adopt this suggestion. There were no other substantive comments on this section, which we have adopted with some editorial changes and the addition of a paragraph pertaining to the failure of an adulterated or substituted result to reconfirm.

§40.203 What problems cause a drug test to be cancelled unless they are corrected?
This section is based on §40.201 of the NPRM and concerns “correctable flaws.” Commenters generally approved the proposed provision, but had varied suggestions. As in the case of fatal flaws, one suggestion was to allow employers to cancel tests in the case of an uncorrected flaw. As we said in that case, we believe that MROs are the best party to take all such actions in the drug testing program. Two commenters disagreed concerning the situation of a missing employee signature coupled with a lack of collector notation of the omission: one said it should be a fatal flaw and the other said it need not be even a correctable flaw. We believe that the NPRM formulation of making this situation a correctable flaw makes the most sense, giving due regard both to the need for completeness of the documentation and the ability to work around inadvertent administrative mistakes.
A commenter suggested that an incorrect employee social security number (SSN) or other ID number (e.g., a transposition of numbers) should not be a fatal or correctable flaw. We agree with this comment. We also believe that a minor transposition error is the kind of irregularity that would not cause a test to be cancelled (see §40.209). If an ID number is completely wrong (e.g., appears to be a different number altogether) is too badly garbled to be useful in establishing the employee’s identity, we view the number as having been omitted, which is a correctable flaw under paragraph (c). Another commenter suggested that the combination of a wrong ID number and a missing employee signature should be a fatal flaw. In our view, both of these items independently are correctable flaws, meaning that if either is left uncorrected the test is cancelled. This is a sufficient safeguard, we believe.

§40.205 How are drug test problems corrected?
This provision is based on proposed §40.203 and concerns how correctable flaws and other problems are corrected. There were few comments on this section. One commenter said there should be a time limit (e.g., five days) for making corrections, and that errors should be taken into account during verification. We agree that corrections should be timely, and while we do not believe that an absolute “statute of limitations” is appropriate, we have added language directing parties to supply this information on the same business day on which they are notified of the problem, transmitting it by fax or courier. Aside from fatal or uncorrected flaws that cause a test to be cancelled, there is no role for consideration of these kinds of mistakes in the verification process, which focuses on whether there is a legitimate medical explanation for a test result.
Another comment suggested that the use of a non-DOT form could be corrected by annotating the remarks section of the non-DOT form with the needed information. We do not object to this form of correction in the situation where the form was used out of necessity (e.g., only form available for a post-accident test), though we do not think it is necessary to include this point in the rule text. It would obviously be contradictory to use this approach where the non-DOT form was allegedly used “inadvertently,” since a collector who noticed the use of the form sufficiently to make the annotation would clearly have been aware of what form he or she was using.

§40.207 What is the effect of a cancelled drug test?
This section is based on §40.205 of the NPRM. There was only one comment, which asked for guidance on what to do if an employee with a confirmed positive test had his or her test cancelled because of a fatal or uncorrected flaw. Other provisions of this part determine what action the employer is authorized or required to take. For example, following a cancellation of a verified positive test because a split specimen was unavailable for testing, there must be an immediate recollection under direct observation.

§40.209 What is the effect of procedural problems that are not sufficient to cancel a drug test?
There were few comments on this section, which is based on §40.207 of the NPRM. The NPRM version stated a general principle: tests cannot be cancelled based on an error that does not have a significant adverse effect on the right of the employee to have a fair and accurate test. The point of this proposal was to prevent administrative or judicial decisions invalidating drug tests that were fair and correct, but had certain de minimis irregularities. One commenter objected to this principle, saying that tests should be cancelled in these situations. Other commenters were supportive.
Because of comments to other sections of the rule asking for clarification about whether certain mistakes in the process should be the basis for cancellation, and on the basis of the Department’s experience in dealing with issues in many drug testing cases, we have decided to add to this section a list of matters that, consistent with this principle, never result in the cancellation of a test. This is not an exclusive or exhaustive list. These matters must be documented, and may result in corrective action for employers or service agents involved, but the proper remedy is not to cancel the test. This is a safety rule, and it is not consistent with safety to permit someone with a positive drug test to continue performing safety-sensitive functions because a collector made a minor paperwork error that does not compromise the fairness or accuracy of the test.
One of the points we make in this section is that a urine collection or an alcohol test must not be cancelled solely because the collector, BAT, or STT has not met training requirements. Such a test would be cancelled only if there were a fatal flaw or other circumstances requiring cancellation. However, an organization that had a pattern or practice of using untrained collectors, BATs, or STTs would be subject to DOT enforcement action (in the case of an employer) or a PIE (in the case of a C/TPA or other service agent).

Subpart J – Alcohol Testing Personnel
Generally speaking, there were far fewer comments on the alcohol testing portions of the rule than on the drug testing and other sections. Throughout much of the alcohol testing portion of the rule, one commenter provided extensive rewrites of the proposed regulatory text. These comments were clearly the product of substantial and thoughtful work on the commenter’s part. For the most part, however, the suggested rewrites did not propose significant substantive changes in the proposed text. We will not discuss these rewrites on a paragraph-by-paragraph basis, except where they raise a substantive point that calls for a response.

§40.211 Who conducts DOT alcohol tests?
The only comments on this section had to do with the limitation on supervisors serving as BATs or STTs for their own subordinates. Some commenters said that this restriction should be modified, since many supervisors had been trained as BATs and there were some situations, such as ships at sea, where supervisors might be the only BATs or STTs available. We note that the proposed regulation already permitted supervisors to serve as BATs and STTs if no one else were available and DOT agency alcohol testing regulations allowed this practice. As in the case of collectors in the drug testing program, we have used the term “immediate” supervisors to indicate that someone higher up in the chain of command was not limited by this restriction.

§40.213 What training requirements must STTs and BATs meet?
The Department has revised this training both in response to comments and to parallel, as much as feasible, the training requirements for collectors in the drug testing program. One comment we adopted in both places was to permit use of a variety of training media (e.g., classroom instruction, internet, video, CD-ROM) for the academic portion of the training. For the proficiency demonstration part of the training, however, absent technological means of real-time monitoring and evaluation of actual proficiency demonstrations, in-person monitoring would be necessary. We also replaced the proposed “sufficiently knowledgeable” language referring to trainers, which commenters said was too vague, with a series of criteria relating to experience or course work in the testing field.
One commenter suggested a list of scenarios that should be randomly included in the three consecutive error-free collections needed to demonstrate proficiency for BATs. Without specifically endorsing the commenter’s list, we believe that this is a useful suggestion. The Department’s guidance on training will include a list of this type for use of persons conducting training.
As in the case of collectors in the drug testing program, BATs and STTs would have to undergo refresher every five years, and error correction training when needed. Most commenters on the subject favored these kinds of training, though some had reservations about what they viewed as the higher costs of the training. In this matter, we believe that insistence on high training standards is no vice, and moderation in the pursuit of a well-trained work force is no virtue. Such a work force is vital to the integrity of the program.
As in the drug testing collector training, some commenters favored waiting until more than one error resulting in cancellation of a test had occurred before requiring error correction training. As in that case, we believe that any such event creates an important training opportunity, to make sure that the individual does not make the same mistake in the future.

§40.215 What information about the DER do employers have to provide to BATs and STTs?
Proposed §40.215 proposed various record retention and information requirements for organizations employing BATs and STTs. Because we believe it would relieve paperwork burdens for employers and C/TPAs to have BATs and STTs maintain documentation of their training and qualifications (as §40.213 provides), the only remaining portion of this section is proposed paragraph (c). This paragraph, on which there were no substantive comments, tells employers to provide to BATs and STTs the name and phone number of a DER.

§40.217 Where is other information on the role of STTs and BATs found in this regulation?
This is another in the series of cross-reference sections, pointing readers to other sections of the rule relevant to the functions of BATs and STTs.

Subpart K – Testing Sites, Forms, Equipment and Supplies Used in Alcohol Testing
§40.221 Where does an alcohol test take place?
We adopted this provision without substantive change.

§40.223 What steps must be taken to protect the security of alcohol testing sites?
We adopted a comment to include ASDs in the requirement to secure testing devices when they are not being used. In response to another comment, we created an exception to the rule that BATs and STTs may not leave the testing site when a test is in progress. The exception is for a situation in which the BAT or STT must notify a supervisor or contact a DER for assistance in the case an employee or other person who obstructs, interferes with, or unnecessarily delays the testing process. Otherwise we have adopted the proposed section without substantive change.

§40.225 What form is used for an alcohol test?
Most of the comments on this section focused on changes commenters sought in the ATF. The form has been revised, and we have included it at Appendix F. Its use will become mandatory on August 1, 2001. We have also modified the language concerning foreign-language versions of the form to be consistent with the parallel provision concerning the CCF.

§40.227 May employers use the ATF for non-DOT tests, or non-DOT forms for DOT tests?
This section parallels the requirements for use of the CCF in the drug testing program. The few comments on the section were supportive of the Department’s approach.

§40.229 What devices are used to conduct alcohol screening tests?
We adopted one comment, including a clarifying note in §40.231 that only EBTs listed in the NHTSA CPL without an asterisk can be used in the DOT alcohol testing program.

§40.231 What devices are used to conduct alcohol confirmation tests?
We adopted one of several editorial comments we received on this section from a commenter, which is to remove the word “sequential” from the requirement that an EBT print a unique number on each copy of the result. As the commenter noted, the important thing is for the same unique test number to be displayed before the test and printed out on the result.

§40.233 What are the requirements for proper use and care of EBTs?
A number of commenters said it was unclear in the proposed version of this section who was responsible for what. To address this problem, we place responsibility on the user of the EBT, who could be an employer or a service agent. We asked in the preamble to the NPRM whether we should retain the requirement for quality assurance plans (QAPs). Most commenters favored retaining this requirement, and we have done so. We are not specifying in the rule, however, who is authorized to perform various maintenance, calibration, etc. functions, as one commenter suggested. We are not in a good position to determine who can best perform these functions.

§40.235 What are the requirements for proper use and care of ASDs?
Most of the comments on this section were editorial. One commenter expressed concern that the section appeared to focus on saliva ASDs to the exclusion of breath ASDs. This is not the case. These sections are derived from provisions of the existing regulation that apply to breath devices as well as saliva devices. Because the “use and care” requirements for EBTs of §40.233 also apply to breath ASDs, we have added a cross reference to §40.233 for clarity.

Subpart L – Alcohol Screening Tests
§40.241 What are the first steps in any alcohol screening test?
Many comments on this section were parallel to the comments on §40.61. In response to the concern about tests not being scheduled in advance, we changed the language to refer to situations in which tests were scheduled. We also added language telling BATs and STTs to begin testing without “undue” delay. We did not adopt comments suggesting that it was appropriate for the testing process to wait upon the arrival of employer or employee representatives.
One commenter noted an inconsistency between the way the NPRM treated refusals to sign the certification on the drug and alcohol testing forms, respectively. In the drug testing case, the collector is directed to note the problem in the remarks section of the form and continue with the test. In the alcohol testing case, the BAT or STT is directed to treat the problem as a refusal to test. We agree that these provisions should be consistent, and we have changed the alcohol procedure to be like the drug procedure.

§40.243 What is the procedure for an alcohol screening test using an EBT or non-evidential breath ASD?
Commenters had a variety of concerns about this section. One commenter asked if showing the employee the sequential number displayed on the device has been omitted from this provision. It has, and the omission was intended. We do not believe that this action is necessary to maintain the integrity of the process. In addition, these number displays are not available on all devices,such as some types of ASDs.
Another commenter had several suggestions for elaborating on instructions to the BAT or STT as part of the preliminary portion of the testing process. We will consider including these suggestions in guidance. Another commenter asked us to specify the number of times an employee could blow into a breath device. We do not think that this is necessary. The point is to complete the test successfully. If it becomes apparent that the employee cannot provide sufficient breath to activate the device, then we expect the BAT or STT to use good judgment in determining when to begin the “shy lung” procedure.
A commenter suggested allowing the result printout to be attached either to the front or the back of the ATF. We will adopt this comment in our pending revision of the ATF. Another suggestion was to use tamper-evident tapes that do not discolor over time. We think that this is a good idea, but not one that we need to mandate in rule text. We have adopted a commenter’s suggestion that a self-adhesive label that is tamper-evident can be used to affix a result printout to the ATF.

§40.245 What is the procedure for an alcohol screening test using a saliva ASD?
The Department is adopting the proposed section without substantive change. One commenter asked to include material pertaining to new evidentiary saliva devices. At the time of the publication of this rule, NHTSA is looking at such devices, but NHTSA’s review is not complete. NHTSA is considering modifying its model specifications for evidential breath testers to accommodate technologies that measure alcohol in other bodily fluids, such as saliva. If adopted, such changes would also require technical adjustments to Part 40 so that both the NHTSA action and Part 40 requirements worked smoothly in concert. Subsequent to this revision of Part 40, any proposed modifications to NHTSA model specifications or Part 40 to accommodate the above advances in technology would be published in the Federal Register, so that the public may comment on them before any changes are made final.
Another commenter said that the ATF can get too sloppy when the STT attempts to use the same form for two separate devices. There is no mandate to use the same form. If one form is getting too cluttered, the STT can use a new form for the part of the process involving the second device. This commenter also said that, in the event the device does not activate on the first try, the STT should not have to place the device in the employee’s mouth for the second attempt. We believe that maintaining this requirement is useful to ensure that the second attempt is more likely to succeed (e.g., in a situation in which the employee has used the device incorrectly at first). This commenter also suggested that there may be situations in which it is not possible to conduct a new test on an EBT, when the STT could not successfully follow ASD procedures. We agree with the commenter that the regulation should include language to address this situation, and we have added a provision to §40.271(a)(3) for this purpose.

§40.247 What procedures does the BAT or STT follow after a screening test result?
This section is also substantively unchanged from the NPRM. One commenter preferred splitting the section into several sections, believing that this would make the requirements more clear. Paragraphs (a), (b), and (c) each are devoted to a single situation (test result of less than 0.02, result of 0.02 or greater, invalid result). We believe this organization is sufficiently clear. This commenter also suggested that we clarify that the employee must be observed during the waiting period in all circumstances. We agree, and we have added language to this effect to §40.251(a)(1). The purpose of this observation is to ensure that the employee remains under the control of responsible personnel during the waiting period and does not take any actions that could interfere with the successful completion of the testing process.
Several comments asked that BATs be able to transmit test results to employers via C/TPAs, acting as intermediaries. Consistent with the Department’s decisions in the drug testing part of the rule, the final rule will permit transmission of negative results by this means. (We will not permit positive results to be sent in this way. For safety’s sake it is essential that these results be transmitted immediately and directly since, unlike drug test results, positive alcohol test results involve impairment.) Another commenter suggested that the ATF include a provision for a statement or check box to indicate that the employee had received instruction about the waiting period between the screening and confirmation tests. We will consider doing so as part of our pending revision of the ATF.

Subpart M – Alcohol Confirmation Tests
§40.251 What are the first steps in any alcohol confirmation test?
One commenter suggested editorial changes to clarify the timing of the waiting period and the confirmation test, in paragraph (a)(1). We have adopted this language. We have not adopted other editorial suggestions for this section, because we believe they are not necessary to clarify the proposed language. We disagree with a comment suggesting that conducting a confirmation test more than 30 minutes after the screening test should not be permitted. While, as paragraph (a)(1) states, it is desirable that the confirmation test begin within 30 minutes, we realize that circumstances (e.g., transportation from the screening test site to a different confirmation test site) could delay the test past this point. Better a delayed test than none at all.

§40.253 What are the procedures for conducting an alcohol confirmation test?
At a commenter’s suggesting, we added the word “conducting” to the first line of this section. Consistent with §40.243, we have added language saying that a self-adhesive label that is tamper-evident can be used to affix a result printout to the ATF. The section is otherwise unchanged from the NPRM version. We do not believe extensive editorial changes are needed. One commenter said that all test results of 0.02 or greater made on a defective machine before corrective action is taken must be cancelled. This point is covered by §40.267(c)(5). We will leave the word “sequential” in paragraph (f). This section involves the use of EBTs, all of which have sequential test number displays.

§40.255 What happens next after the alcohol confirmation test result?
Aside from a few editorial changes and additional requests that C/TPAs be able to act as intermediaries in the transmission of results, there were no comments on this sections. We have addressed the C/TPA transmission issue elsewhere. We have adopted the proposed section without change.

Subpart N – Problems in Alcohol Testing
§40.261 What is a refusal to take an alcohol test, and what are its consequences?
In response to a comment, we added language clarifying that the failure to remain at a testing site until the testing process was complete constitutes a refusal to test. We have deleted the provision treating refusal of the employee to sign the ATF certification in Step 4 as a refusal to test. Otherwise, the section is substantively unchanged from the NPRM. We have not made extensive editorial changes.

§40.263 What happens when an employee does not provide a sufficient amount of saliva for an alcohol screening test?
There was no substantive comment on this section, and we have adopted it unchanged from the NPRM.

§40.265 What happens when an employee does not provide a sufficient amount of breath for an alcohol test?
We have revised this provision to be parallel, in many respects, with the “shy bladder” procedure in the drug testing portion of the rule. These changes include providing that the evaluating physician must have expertise in the issues raised by the employee’s failure to provide a sufficient amount of breath and that the employee must obtain the evaluation within five days. (The physician could be a specialist, but need not be. What is important is that the physician have sufficient expertise to deal effectively with the issues presented in the employee’s case.) Three commenters suggested that this time period should be changed to one, three, or seven days rather than five days. We believe that the five-day period should be generally sufficient and is consistent with other medical evaluation provisions of the rule.
However, the Department is aware that, in some cases, it may be difficult for an employee to secure, on his or her own, an appointment for this evaluation in a short period of time. Consequently, the Department does not regard it as a refusal to test if the employee is unable, after making good faith efforts, to get the appointment within the 5-day period. However, the employer should do everything feasible to assist the employee in finding and getting an appointment with an appropriate physician.
A commenter suggested giving employees additional attempts to provide a sufficient amount of breath to complete a test. We have modified this section to permit an additional attempt, if the BAT or STT believes that it would be useful (e.g., because the employee came close on the second attempt or made a mistake in using the device that could be readily corrected). It is not mandatory for the BAT or STT to provide this third attempt. At this commenter’s suggestion, we have also added language telling the BAT or STT to instruct the employee on the proper use of the device.

§40.267 What problems always cause an alcohol test to be cancelled?
One commenter disliked the use of the word “cancelled,” preferring “invalid.” The term “invalid” has a specific meaning in the drug testing part of the rule, so we think it better to avoid the word here. “Cancelled” has the same meaning here as it does in drug testing, and should not cause any confusion. A commenter suggested adding rule text requiring BATs and STTs to notify DERs within 48 hours of the discovery of a fatal flaw. We agree that prompt notification is important, and we have added language to §40.273 to this effect. We put this provision into §40.273 so that it applies to all cancellations.

§40.269 What problems cause an alcohol test to be cancelled unless they are corrected?
There were no substantive comments on this section, which is unchanged from the NPRM.

§40.271 How are alcohol testing problems corrected?
As discussed above, we have added a new paragraph (a)(3) to this section, concerning situations in which a new testing device is not available at the testing site. We have also added a new paragraph (c), clarifying that when a correctable flaw cannot be corrected, the test must be cancelled. We did not receive substantive comments on this section, which is otherwise unchanged from the NPRM.

§40.273 What is the effect of a cancelled alcohol test?
There were no substantive comments on this section, the proposed text of which is unchanged from the NPRM. We have added new paragraphs ( c) and (d), which respectively call for notification of the DER and state that a cancelled test is not intended to provide a basis for a subsequent test under company policy,

§40.275 What is the effect of procedural problems that are not sufficient to cancel an alcohol test?
§40.277 Are alcohol tests other than saliva or breath for screening and breath for confirmation permitted under these regulations?
There were no substantive comments on these sections, which are unchanged from the NPRM.

Subpart O – Substance Abuse Professionals and the Return-to-Duty Process
§40.281 Who is qualified to act as a SAP?
§40.283 How does a certification organization obtain recognition for its members as SAPs?
These sections were both based on proposed §40.281. We received extensive comment on the question of who should be viewed as eligible to perform SAP functions. Many individuals, professional organizations, and certification organizations (e.g., for drug and alcohol counselors, marriage and family therapists, licensed professional counselors) asserted that their qualifications were as appropriate, if not more so, than groups and professions which the rule views as eligible. Without denigrating the qualifications of any individuals, professions, and organizations, the Department believes that the proposed rule continues to identify those professions and organizations that currently are best equipped to perform the SAP function in the DOT drug and alcohol testing program.
This is a program that is national in scope, and we believe that, for persons who wish to act as SAPs based on membership in a licensed or certified profession, it is reasonable to require that the licensure or certification be available in all U.S. states. For persons who wish to act as SAPs based on an organizational certification, the Department has set forth criteria in Appendix E for the requirements that must lie behind such certifications. The Department developed these criteria under the existing rule as a means of evaluating applications to the Department for SAP eligibility, and they are consistent with the requirements of certification organizations that are already part of the SAP program.
The NPRM proposed to require organizations that certify counselors to obtain National Commission for Certifying Agencies (NCCA) accreditation before submitting their requests to have the Department consider their certified counselors for inclusion in the SAP definition. The NPRM also proposed that the two certifying organizations whose counselors are already in the SAP definition (i.e., the National Association of Alcoholism and Drug Abuse Counselors Certification Commission (NAADAC) and the International Certification Reciprocity Consortium / Alcohol and Other Drug Abuse (ICRC)) would not be required to have NCCA accreditation because they have already been through a rigorous Department process prior to their inclusion.
Commenters overwhelmingly supported the concept of having certification organizations obtain NCCA accreditation prior to submitting their requests to have their certified counselors considered for inclusion to the Department. A few organizations opposed any type of review by any organization, including the Department, prior to having their certified counselors added to the SAP definition. A few commenters wanted the Department to maintain total control of the review process – a process that proved entirely too burdensome and time consuming for us. Still other commenters wanted us to clarify that the NCCA accreditation requirement (and Appendix F of Part 40) applied solely to certifying organizations wishing to have their counselors included in the SAP definition and not to physicians, social workers, psychologists, and employee assistance professionals; and not to NAADAC and ICRC. Those who commented on NAADAC and ICRC, did not believe NCCA accreditation was necessary for those two groups.
Part 40 will require certification organizations wishing to have their certified counselors included in the SAP definition to meet the requirements (which includes NCCA accreditation) at Appendix F of Part 40 prior to asking the Department to review their inclusion proposals. The Department will still receive and review all proposals for inclusion based upon Appendix F standards. It is important to note that NCCA accreditation is simply one of the prerequisites for inclusion, but it represents an area of review that the Department found to be the largest barrier to our streamlining the process for reviewing certification groups’ application materials and for evaluating the quality of those groups’ certification testing processes.
Because NAADAC and ICRC excelled in the Department’s previous review process, they will be compelled neither to have NCCA accreditation nor to complete the process again. Physicians, social workers, psychologists, and employee assistance professionals were never intended to have NCCA accreditation. This requirement is not for them: it is only for certification organizations wishing to have their certified counselors added to those of NAADAC and ICRC.
A few commenters suggested that all SAPs be certified by the Department. One suggested that we support any future proposals by the Substance Abuse and Mental Health Services Administration to certify drug and alcohol counselors. While we support efforts to ensure that SAPs are better trained (and Part 40 has new training requirements for SAPs), the Department lacks the expertise, personnel, and time needed to establish and operate a SAP counselor certification effort. Like the lone commenter mentioned in this paragraph, we would support efforts by HHS to develop certification standards and subsequently certify all drug and alcohol counselors.
As was the case with commenters on MRO training, most commenters on SAP training thought that self-certification was not adequate. Many comments favored more formal training requirements for SAPs, like those proposed for MROs. Some of these comments mentioned situations in which they believed SAPs had made poor decisions based on an incomplete understanding of their role under the DOT rules.
The Department is persuaded that more formal SAP training is appropriate. Like MROs, SAPs are highly-qualified professionals. They play a key role in the return-to-duty process, which has important safety implications. In addition to their professional qualifications, they need to be very aware of their role in implementing DOT agency drug and alcohol testing rules. Consequently, the Department is revising SAP training requirements to parallel the training requirements for MROs. The Department is aware that there are not currently an array of SAP courses analogous to the MRO courses that medical groups currently present. For this reason, the SAP qualification training deadline has been extended to December 2003. However, the Department anticipates that, in the time permitted for new and current SAPs to meet this requirement (see §40.281(c(3)), the demand for training will lead to a supply becoming available. We believe that organizations will take the opportunity to create appropriate training courses and materials.
Like qualification training for MROs, SAP qualification training includes a requirement for an examination. However, the Department does not believe that this examination need be a formally designed and validated examination. SAP functions are narrower in scope and less complex than MRO functions, and the examination can therefore be simpler, in our view. The purpose of SAP training and the examination is not to teach people how to be clinicians, but rather to help SAPs learn how to operate in their specialized role within the DOT regulatory framework.
As with MROs, we have added a continuing education requirement to keep SAPs current on program requirements and issues. This continuing education must involve a test or other assessment tool to help SAPs determine whether they have successfully learned the material.

§40.285 When is a SAP evaluation required?
This section is based on §40.283 of the NPRM. Consistent with other provisions of the rule, we have added adulteration and substitution results to the situations requiring SAP evaluations. We disagree with a commenter who said that an alcohol test result of 0.04 or greater was not a violation of DOT agency alcohol regulations. It is a violation, and a SAP evaluation is a necessary part of the return-to-duty process following such a violation. Some comments questioned whether a SAP evaluation was necessary in all cases (e.g., including pre-employment tests) following a violation. It is, and we have added some clarifying language to this effect. In the case of a pre-employment test violation, the employer to whom the individual had applied would be responsible for providing the individual information about SAP resources and the return-to-duty process, even if the employer wanted no further relationship with the individual.
A commenter asked whether a SAP evaluation would be needed for an employee who had a DUI/DWI charge against him or her in a private automobile. The answer is no: under Part 40 only a violation of DOT agency drug and alcohol testing rules triggers the requirement for a SAP evaluation (though DOT agency rules may impose additional requirements in some cases). Another commenter recommended that applicants who test positive on pre-employment tests should be required to present evidence of having completed the return-to-duty process before being able to work in a safety-sensitive position for another employer. We have addressed this issue in §40.25, concerning inquiries about previous test results.

§40.287 What information is an employer required to provide concerning SAP services to an employee who has a DOT drug and alcohol regulation violation?
This section is based on proposed §40.285 of the NPRM. There were few comments. One asked whether the employer or the employee was to select the SAP. This section does not address selection of a SAP: it just says that the employer has to provide the employee a list of SAPs and how to reach them. The provision does clarify that this requirement applies to all violation situations, including pre-employment tests. If an applicant fails a pre-employment test, the employer must provide this information even if the employer intends not to hire the applicant.

§40.289 Are employers required to provide SAP and treatment services to employees?
This provision is based on proposed §40.287 of the NPRM. Paragraphs (a) and (c) emphasize the employer’s provision of SAP services. An employer may or may not provide SAP-related services to employees. An employer may or may not pay for such services. These are matters the Department leaves to employer discretion or labor-management negotiations. One commenter suggested that employers be required to cover these services in their health plans. We believe that, as the commenter acknowledged, imposing coverage requirements on health care providers or insurers is outside the Department’s jurisdiction.
The proposed §40.287 included two paragraphs telling employers that they must ensure the SAPs used to evaluate employees before they return to duty meet certain qualifications. In view of the SAP training and qualification provisions of §40.281 of the final rule, we believe these paragraphs are duplicative, and we have deleted them. This section continues to emphasize that, before an employee who has violated a DOT agency drug and alcohol testing regulation may return to safety-sensitive duties, the employee must successfully complete the SAP evaluation/return-to-duty process.

§40.291 What is the role of the SAP in the evaluation, referral, and treatment process of an employee who has violated DOT agency drug and alcohol testing regulations?
The content of proposed §40.291 has been moved to §40.355(a). This section now concerns a different subject, stating the general duties of SAPs.

§40.293 What is the SAP’s function in conducting the initial evaluation of an employee?
The final rule has no equivalent to proposed §40.289, the content of which duplicates other provisions in this subpart. There were few comments concerning §40.293, and they were mostly supportive. Some comments did favor allowing C/TPAs to transmit SAP reports to employers. As discussed in the “Principal Policy Issues” section of the preamble, we have chosen not to permit this, as a means of preventing anyone from having the opportunity to alter the SAP’s report and recommendations.
We have added three new points to this section. First, as discussed in the “Principal Policy Issues” section of the preamble, we believe that there are no circumstances in which it is appropriate for a SAP to find that a violator of our regulations is not in need of education and/or treatment. Therefore, paragraph (b) requires that SAPs make a recommendation for education and/or treatment in every case. Second, we have become concerned that we have not previously given SAPs guidance with respect to employees’ stories that minimize the seriousness of their violations, analogous to the guidance we give MROs with respect to legitimate medical explanations. Therefore, paragraph (f) specifically forbids SAPs from taking certain kinds of factors into account in making their recommendations.
Third, while we are not making quantitations routinely available to SAPs in drug testing cases (see discussion in “Principal Policy Issues”), we believe it is very important for MROs and SAPs to have good communications about employees. Paragraph (g) explicitly authorizes SAPs to consult with MROs, and tells MROs they must cooperate with SAPs in these consultations.

§40.295 Can employees or employers seek a second SAP evaluation if they disagree with the first SAP’s recommendations?
The purpose of this section is to prevent employers and employees from forum shopping until they get a SAP evaluation they like. Most comments supported the proposed prohibition on second opinions, though one commenter thought this should be permitted if the original SAP does a bad job. The difficulty with this suggestion is that a party’s perception of the quality of the SAP’s work is likely to be influenced on whether the SAP made a recommendation the party feels is in its interest. We believe that a prohibition on second opinions is the only way to prevent forum shopping.
One commenter suggested that we remove the reference to the SAP being suitable to the employer. We believe the proposed language in this section is unnecessary , and we have deleted it. Also, to tighten the provision, we have added a sentence saying that if, notwithstanding the regulatory prohibition, an employee gets an evaluation from a second SAP, the employer must not pay any attention to it.

§40.297 Does anyone have the authority to change a SAP’s initial evaluation?
Several commenters noted that the language of the proposed section appeared to prevent even the SAP who originally made the recommendation from modifying his or her own recommendation. We did not intend to prevent SAPs from modifying their own recommendations, and we have added clarifying language that permits SAPs to do so when they receive new or additional information.

§40.299 What is the SAP’s role and what are the limits on a SAP’s discretion in referring employees for treatment and education?
A number of commenters appeared to prefer stating one of the exceptions to the rule against self-referral in terms of SAPs located in “rural and remote areas” rather than the NPRM’s “general commuting area” language. The Department does not believe that this would improve the clarity of the section, since “rural” and “remote” are rather subjective terms. The exception is intended to apply, in any case, to a situation in which there is no other source of services reasonably available in the vicinity. For example, if an employee had to make an overnight trip to get to another source of services, we would not consider it reasonably available.
One commenter wanted to consider referrals to spouses as prohibited by this section. We believe this is covered by the prohibition on referrals to people with whom the SAP shares a financial interest. Another commenter wanted to create a fifth exception for in-house corporate SAPs. We believe that the second and third exceptions are adequate to cover this situation. We also received a suggestion to delete the signed statement requirement of proposed paragraph (d). Given the specificity of the other requirements of the section, we do not believe that this signed statement adds much of substance, and we have deleted it in the interest of reducing paperwork.

§40.301 What is the SAP’s function in the follow-up evaluation of an employee?
Comments were generally supportive of this section. A few comments pointed out that some current DOT agency regulations do not make use of the SAP process. This is true. However, DOT agencies will amend their regulations to conform to Part 40 before the effective date of this part. Another commenter asked for clarification of who makes a return-to-duty determination. SAPs simply determine whether an employee has successfully demonstrated compliance with the SAP’s recommendations. As this section and §40.305 make clear, only the employer decides whether, after all prerequisites have been met, the employee returns to safety-sensitive duties. In response to comments that employers should be notified if the SAP process is taking longer than expected (e.g., because the employee has not made expected progress in treatment), we have added a provision requiring the SAP to provide written notice to the employer when the employee has not demonstrated successful compliance on follow-up evaluation.
The Department understands that not every employee will make strides in dealing with a drug or alcohol problem sufficient to receiving a SAP follow-up report indicating that he or she has demonstrated successful compliance with the SAP’s recommendation. When this happens, we believe that it is important that the employer receive a SAP follow-up report outlining the reason(s) why the employee has not demonstrated successful compliance. We understand that some employees may be actively involved in carrying out their education and/or treatment plan and simply need additional time to complete the work. Others may have been non-participants in a SAP-recommended program. Therefore, when the SAP determines that the employee has failed to demonstrate successful compliance, we have no objection to having the employer deciding to allow an additional SAP follow-up evaluation to be made consistent with the employee’s progress (or lack of progress) and with employer policy and/or labor-management agreements. Nor will the Department object if the employer chooses instead to take other personnel actions consistent with employer policy and/or labor-management agreements.

§40.303 What happens if the SAP believes the employee needs additional treatment, aftercare, or support group services even after the employee returns to safety-sensitive duties?
As discussed in the “Principal Policy Issues” section of the preamble, we have deleted a proposed requirement that employers “monitor” returned employees’ aftercare. This was the subject of the bulk of the comments on this section. The section now gives discretion to employers concerning their monitoring and enforcement of SAP aftercare recommendations. We strongly recommend that employers play an active role in ensuring that employees who have returned to work following a violation comply with aftercare recommendations. This is very important both for safety and the welfare of the employees. The rule also states that employees are obligated to comply with these SAP recommendations and are subject to employer discipline if they do not.

§40.305 How does the return-to-duty process conclude?
This section underlines the point that it is the employer, and the employer alone, who is responsible for deciding whether an employee who has violated DOT agency drug and alcohol testing rules will return to work. A determination by the SAP that the employee has successfully complied with the SAP’s recommendations is a prerequisite to the employee’s return to duty. So is a negative result on a subsequent return-to-duty test. But only the employer can decide whether or not to put the person back to work. SAPs do not make “fitness for duty” decisions, and employers should not ask them to do so. Commenters asked that we make these points clear. We think this section is as clear on this point as we can make it.

§40.307 What is the SAP’s function in prescribing the employee’s follow-up tests?
§40.309 What are the employer’s responsibilities with respect to the SAP’s directions for follow-up tests?
As discussed in the “Principal Policy Issues” section of the preamble, the Department has decided to retain the “at least six follow-up tests in the first 12 months” formulation for follow-up testing. In response to requests from commenters, we have clarified that this follow-up testing requirement “follows the employee” through job changes and breaks in safety-sensitive service. The six tests must occur during the first 12 months of safety-sensitive service after return-to-duty, regardless of for whom or when that service is performed.
Of course, SAPs have the discretion to require more follow-up tests than the minimum. One commenter suggested that SAPs negotiate the number of follow-up tests over the minimum with the employer. We did not adopt this suggestion, because this is intended to be a clinical determination, not subject to economic or policy give-and-take. Employers are obligated to follow the SAP’s follow-up testing plan. All parties involved should be aware that, under this rule, all employees who return to work after a violation will have a follow-up testing requirement with which employers and employees must comply.

§40.311 What are requirements concerning SAP reports?
Most of the comment on this section concerned the issue of C/TPAs acting as intermediaries in the transmission of SAP reports to employers. As discussed above, the Department is not permitting C/TPAs to act in this capacity. SAPs must send their reports directly to the DER. The report must be on the SAP’s own letterhead, not that of a C/TPA or another service agent.
In response to a comment on the content of the SAP report, we have used the term “date(s)” rather than “date” to cover the possibility that assessments will happen over a period of time longer than a single meeting. We have also clarified that “reason for the assessment” refers to the date and nature of the violation of DOT rules, as a commenter requested, and as DOT’s SAP Guidelines outline.

§40.313 Where is other information on SAP functions found in this regulation?
This is the last of the regulation’s sections providing informational cross-references to other provisions concerning, in this case, SAP functions.

Subpart P – Confidentiality and Release of Information
§40.321 What is the general confidentiality rule for drug and alcohol test information?
Several commenters disagreed with the proposal to continue the Department’s ban on blanket releases. These commenters believed that permitting blanket releases would facilitate the flow of information among parties who needed to know, for example, whether an applicant for a job had previously violated a DOT regulation. Other commenters favored retaining this proposal in order to protect employee privacy. The Department believes that the principle of specific written consent for any release of test result or medical information to third parties is critical to protect employees’ legitimate expectations of privacy and confidentiality in the testing program. Permitting blanket releases is directly contrary to this principle. The Department will include the proposed provision in the final rule.

§40.323 May program participants release drug or alcohol test information in connection with legal proceedings?
The existing rule and the NPRM both provide that in a proceeding brought by, or on behalf of, an employee, resulting from a positive test (e.g., a lawsuit or grievance), the employer may release employee test result information without the employee’s consent. One commenter suggested that we add references to substituted and adulterated tests and other refusals to test. We have done so.
Another commenter raised the issue of a different kind of legal proceeding. The commenter asked whether otherwise confidential information could be released in a personal injury lawsuit where the employee’s conduct was an issue (e.g., a truck or bus driver involved in a collision). We believe that, if a court orders the production of such information because it is relevant in such a proceeding, it is reasonable for the employer to provide it without getting the employee’s consent. In this situation, the requirements of justice in the litigation outweigh the employee’s privacy interest. We have added a paragraph to this effect. We also added a paragraph telling a service agent who is holding this information to provide it to the employer when the employer requests it for use in a legal proceeding covered by this section.

§40.327 When must the MRO report medical information gathered in the verification process?
This section provides that, under certain circumstances, MROs must provide certain otherwise confidential information to employers and certain other parties. The purpose of providing this information is to enhance safety. Commenters had a variety of concerns about this section. One comment suggested that the medical information be provided in writing in all cases. We think that a prudent MRO may choose to do so, but we do not believe that a regulatory requirement is needed.
Some commenters objected to the paragraph that allows MROs to consult with the employee’s own physician to see if alternate medication might be available that would be less likely to adversely affect safety, saying that MROs should stay out of what looks like a doctor-patient relationship with employees. A few commenters supported this proposal. Under the proposal, the MRO would take this step only with the employee’s consent, and for the purpose of helping the employee find medication that would be compatible with safe job performance. From both the point of view of employee interests and safety, we believe that this proposal is sound, and we have retained it.
One commenter said that Canadian law would preclude a doctor from releasing this information to an employer. We have added a provision saying that if the law of a foreign country, such as Canada, prohibits MROs from providing medical information to the employer, the MROs may comply with that prohibition.
Another commenter pointed out that not only physicians, but also other medical professionals, may make determinations about whether an employee meets physical qualification standards. We have adopted the commenter’s suggestion that the MRO can release information to the “health care provider” involved in this activity. Consistent with the SAP provisions of the rule, we have included SAPs who are evaluating employees as part of the return-to-duty process as a party to whom the MRO can provide information under this sectoin.
Finally, as some commenters requested, we have made it mandatory for MROs to release information under this section if the information is likely to result in the employee being medically unqualified for performance of safety-sensitive duties under a DOT regulation or if the information indicates that continued performance by the employee of his or her safety-sensitive function is likely to pose a significant safety risk. In this case, the Department believes that the safety interest served by the information release outweighs the confidentiality interest of the employee.
We point out that the medical information described in this section cannot be transmitted to employers or other parties using a C/TPA or other service agent as an intermediary. MROs must transmit this information directly to the employer.

§40.329 What information must laboratories and other service agents release to employees?
Proposed §40.329, concerning release of information by MROs to third-party employers, has been deleted, for the reasons given in the “Principal Policy Issues” section of the preamble. This section is based on proposed §40.331 of the NPRM.
One commenter requested that the Department require that laboratories provide all records requested by an employee, as well as a laboratory person to testify in a legal proceeding who has firsthand knowledge of the laboratory, its records, and operating procedures. This commenter also requested that the rule require the laboratory to make records available within 10 days, rather than waiting for payment from the employee. This section does require that laboratories and other service agents provide a “data package” (sometimes referred to as a “litigation package”) upon the employee’s request. We do require that they provide it within 10 business days. The rule also limits the charge the service agent can make for the cost of copying and preparation. We believe these provisions adequately protect employee interests. We do not believe it is necessary, as another commenter suggested, to list the contents of a litigation package, which is quite standard and well understood among laboratories.
We have not adopted the suggestion that laboratories be required to produce witnesses for appearances at legal proceedings. Such an open-ended requirement would impose, in our view, unnecessary costs and burdens on laboratories and other service agents. There are adequate means (e.g., documentary evidence) through which employees can raise issues about the testing process.
The NPRM proposed that laboratories provide to employees, on written request, information relating to the results of relevant HHS certification reviews. One comment supported this proposal, which is consistent with long-standing DOT interpretation of the existing Part 40, while another commenter proposed that the laboratory’s obligation be limited to the latest HHS Federal Register notice listing the laboratory as certified. Based on conversations with HHS staff, we have decided to delete this provision. HHS staff believe that providing this information would unnecessarily intrude on the HHS-laboratory relationship and could result in the introduction of misleading information about the laboratory certification process in legal proceedings involving drug test results.

§40.331 To what additional parties must employers and service agents release information?
This section is based on §40.333 of the NPRM. Some commenters objected to being required to permit DOT representatives to see a broad array of drug and alcohol testing information. DOT has significant safety responsibilities for transportation industries, of which our drug and alcohol testing rules are an important part. As part of its safety mandate, DOT must be able to inspect regulated employers and those who carry out their drug and alcohol testing program responsibilities. DOT cannot do this job unless we have access to all relevant information. We believe it is vital to maintain this provision in the final rule. We would point out, particularly in response to a comment that Canadian MROs could not legally release certain information, that this paragraph focuses on the inspection and review of documents as part of the DOT oversight process, not on release of information to third parties.
Commenters pointed out that, in some jurisdictions, state laws or rules require employers or service agents to provide drug test result information to state law enforcement or safety agencies. To ensure that there is no conflict between Part 40 and these state laws or rules, we have added language (already found in some DOT agency rules) to this section. It says that if requested by a state or local safety agency with regulatory authority over the employer or employee, employers and service agents must provide drug and alcohol test records concerning the employee to the agency. This paragraph also covers Federal agency requests (including requests by DOT, HHS, and the National Transportation Safety Board) for drug and alcohol test records. It should be noted that this paragraph applies only to testing records. It does not authorize provision of specimens.
We have also added a paragraph stating in rule text the advice we have frequently given to employers and service agents faced with subpoenas or other orders directing them, contrary to Part 40 requirements, to produce specimens where Part 40 does not permit. What is a laboratory or other party to do if it gets a request to produce a urine specimen or aliquot for an unauthorized test? The first thing the laboratory should do is to “just say no,” giving this DOT regulatory mandate as the reason. If someone seeks a subpoena or other court order directing the production of the specimen, the laboratory’s attorneys should seek to quash or resist the action, asserting on the basis of this section that such an order is contrary to Federal law and subject to Federal pre-emption (under the existing pre-emption provisions of DOT agency drug and alcohol regulations). In such cases, we suggest that laboratories call the Department to consult about the matter. If a court ultimately issues a binding order requiring the production of the specimen, the laboratory may comply (we do not seek to make laboratories subject to contempt citations). However, as noted above, employers must continue to implement all consequences of a verified positive test required by DOT rules, regardless of the outcome of the unauthorized test or any personnel process decisions flowing from it.

§40.333 What records must employers keep?
This section is based on §40.335 of the NPRM. In response to a number of comments and consistent with decisions reflected elsewhere in this document, proposed requirements for the retention of records concerning training of service agents and signed agreements with service agents have been deleted. Under the final rule, collectors, BATs, MROs etc. will maintain their own training records, and employers will not have this responsibility. The requirement to have signed agreements among employers and all service agents has been deleted.
In response to a comment, we have deleted the word “secure” from paragraph (c), since we agree that control of access is the key point. One comment suggested that service agents should have up to five business days to get information to employers who are being audited. In our view, each DOT agency’s rules and inspection practices should determine how quickly an employer must produce records. The service agent is responsible for meeting the employer’s need to comply with DOT agency requirements.

Subpart Q – Roles and Responsibilities of Service Agents
§40.341 Must service agents comply with DOT drug and alcohol testing requirements?
There was only one comment on the proposed §40.341. A C/TPA wanted C/TPAs to be authorized to act as a DER and to be required to have a certified MRO or administrator in charge. For reasons we have discussed elsewhere, we are not permitting C/TPAs to act as DERs. While we think that training and certification programs for program administrators are a good idea, we do not believe that it is necessary to make them mandatory at this point.

§40.343 What tasks may a service agent perform for an employer?
This is a new section that makes the basic point that service agents can perform for employers those functions authorized by DOT rules. Proposed §40.343 dealt with a different issue. DOT has become aware of reports that, particularly in some industries, service agents have imposed requirements on covered entities that exceed the requirements of DOT rules. Some service agents have made compliance with these extra requirements a condition of approval of an employer’s DOT drug and alcohol testing program. The proposed section was intended specifically to prevent excesses of this kind.
There were few comments on the proposed section. One said that service agents work for employers in capacities other than compliance with DOT rules. This is doubtless true, but is an issue outside the scope of this rulemaking. One commenter suggested that there was a reverse problem, in that sometimes employers asked service agents (e.g., SAPs) to perform tasks beyond what DOT rules require (e.g., make fitness for duty decisions). We have strengthened language elsewhere in Part 40 to emphasize that it is inappropriate to call on SAPs to make these decisions for employers. A third commenter was concerned that the section might inhibit the ability of service agents to advise employers to recommend provisions not covered by DOT rules. Service agents can recommend provisions not covered by DOT rules, but they cannot make adoption of these recommendations a condition of approving employers’ plans for DOT compliance purposes.
The Department has relocated this provision to §40.355(l).

§40.345 In what circumstances may a C/TPA act as an intermediary in the transmission of drug and alcohol testing information to employers?
The proposed §40.345 made the point that a service agent that did not comply with DOT regulations was subject to PIE proceedings. Comments to thisproposal were along the lines of comments on the PIE proposal itself, to which we responded in the “Principal Policy Issues” section of the preamble. The substance of this proposed section has been incorporated in §40.341 of the final rule.
The new §40.345 incorporates the Department’s decision, discussed at length under “Principal Policy Issues,” to permit employers to use C/TPAs for a variety of information transmission functions, such as passing drug and alcohol test results from MROs or BATs to employers. We emphasize four points. First, with respect to any and all of the functions that C/TPAs may perform, the employer has the choice of using a C/TPA as an intermediary or getting the information directly from the party (e.g., the MRO) who generates the information. Second, we direct readers’ attention to Appendix F. C/TPAs may act as intermediaries only with respect to the functions listed in Appendix F.
Third, when C/TPAs act as an intermediary, they must meet all requirements (e.g., concerning confidentiality and timing) that would apply if the party generating the information (e.g., an MRO or collector) sent the information directly to the employer. For example, if a C/TPA transmits the MRO’s drug testing results to DERs, it must transmit each drug test result to the DER in compliance with the requirements for MROs set forth in §40.167. Fourth, as noted in connection with §40.15, employers remain fully responsible for receiving all information and taking all actions required under Part 40 and other DOT agency rule

§40.347 What functions may C/TPAs perform with respect to administering testing?
One comment on this section suggested that it refer to C/TPAs specifically, rather than service agents generally, because the content of the section covered functions that C/TPAs perform and other service agents (e.g., MROs, laboratories) either should not or typically do not perform. We agree with this comment, and we have changed the language of the section accordingly. Another commenter appeared to be confused about the provision telling service agents not to select employees randomly for testing from a “follow-up” pool. This point – which applies to employers as well as C/TPAs – is that follow-up tests are scheduled individually for employees who have returned to safety-sensitive duties after a violation, consistent with the SAP’s plan. It is never appropriate to put returned employees into a pool and select them randomly for follow-up testing. Employees never get advance notice of the time of a follow-up test, but follow-up testing is in no way random. On the other hand, in addition to being subject to follow-up testing, returned employees must be in the regular random testing pool, and are subject to selection for random testing on the same basis as all other covered employees.

§40.349 What records may a service agent receive and maintain?
Some commenters on this section were concerned that because the proposed rule used the general term “service agent” in this section, the section glossed over restrictions on the activities of MROs and laboratories. They suggested that, as in the case of §40.347, we limit the section to C/TPAs. While we agree that C/TPAs perform many record management functions, it does not appear to us that the provisions of this section apply only to C/TPAs. However, in response to the commenters’ concerns, we are prefacing this section with an “except where otherwise specified in this part” statement (we did the same in §40.347). The import of this language is that, where MRO, laboratory, or other provisions of the rule impose requirements or restrictions beyond those of this section, those requirements or restrictions control.
Another comment suggested clarifying that DOT access to service agent records and facilities does not apply to records and facilities not involved in the DOT drug and alcohol testing program. This point seems clear on the face of the proposed and final provisions, so we will not restate the obvious. Another comment objected to requiring this access, and asked for a justification. This is equally obvious: in order to maintain proper oversight of an important safety program, the Department needs access to the records and facilities of those who actually perform program tasks.

§40.351 What confidentiality requirements apply to service agents?
This section is also based on parts of proposed §40.349. A number of comments pertained to proposed §40.349(e), relating to handling of the CCF. There is no equivalent to this proposed paragraph in the final rule. A few comments also supported allowing “blanket” releases of information. As under the present rule, we believe that blanket releases compromise the confidentiality of employee-specific records and are subject to abuse. The final rule continues this prohibition.

§40.353 What principles govern the interaction between MROs and other service agents?
This section is based on §40.351 of the NPRM. Much of the comment concerned the discretion of C/TPAs, acting as an intermediary, to transmit laboratory results to MRO and MRO verification decisions to the employer. As discussed in “Principal Policy Issues” and in connection with §40.345, the final rule permits the latter and prohibits the former.
Some commenters appeared to believe that the proposed section required MROs to exercise full-time, in-person, over-the-shoulder supervision of their staffs. This is not the case. As long as MROs really supervise their staff, this supervision need not always take place at the same site. We are aware that MRO operations may have more than one site and that an MRO cannot be everywhere at once. On the other hand, the rule is intended to prohibit C/TPA staff, working on their own or under C/TPA rather than MRO supervision, from performing MRO staff functions.
To reduce paperwork, we have deleted a proposed requirement for written agreements between MROs and other service agents.

§40.355 What limitations apply to the activities of service agents?
Some commenters on this section favored allowing C/TPAs to act as DERs and to act as an intermediary in transmitting results from laboratories to MROs. Another commenter opposed any “firewalls” between C/TPAs and MROs. As we have explained above, the final rule does not permit C/TPAs to act as DERs or to transmit laboratory results to MROs. In our view, some firewalls between MROs and other participants in the testing process are essential to maintaining the necessary independence of MROs.
Another commenter said that employers, not SAPs, should make follow-up testing determinations. SAPs are used in the return-to-duty process because of their expertise in evaluating individuals with drug and alcohol problems. We believe that their expertise should be used to determine follow-up testing requirements. Employers may know their workers, of course, but they are not typically experts in drug and alcohol abuse evaluation and treatment.
One commenter suggested adding a sentence specifying that MROs could determine that an individual had refused a test, in the context of an adulteration or substitution finding. We agree, and we have added this language.
We have added a paragraph concerning a problem that the Department has occasionally encountered. It states that service agents must not intentionally delay the transmission of drug or alcohol testing-related documents because of a payment dispute or other reasons. Parties can work out disputes among themselves, but it is essential to the safety purposes of this program that drug and alcohol testing results and other information flow freely. As a safety matter, this information must not be held hostage to business disagreements.

Subpart R – Public Interest Exclusions
The Department discussed PIEs extensively in the “Principal Policy Issues” portion of the preamble. We will not repeat this discussion here, focusing instead on points in the individual sections of Subpart R that should be highlighted.
§40.361 What is the purpose of a public interest exclusion (PIE)?
§40.363 On what basis may the Department issue a PIE?
§40.365 What is the Department’s policy concerning starting a PIE proceeding?
These sections emphasize that the basic purpose of PIEs is to protect the public from serious noncompliance on the part of service agents. PIEs are not an exclusive remedy: we can take other actions (e.g., sanctions against employers, referral to the DOT Inspector General) if circumstances warrant. The basic grounds for issuing a PIE are serious noncompliance with Part 40 or DOT agency drug and alcohol testing regulations and failure to cooperate with DOT oversight and enforcement efforts.
Section 40.365 includes a list illustrating the kinds of misconduct that we believe warrant initiating a PIE proceeding. We emphasize that this is not an exhaustive or exclusive list. We can and will initiate PIEs on the basis of other fact situations, if warranted. However, this list should give interested persons a good idea of the Department’s policy concerning the level of seriousness that we intend to be the basis for PIE actions. The items on the list all concern such matters as safety, the outcomes of test results, privacy and confidentiality, due process and fairness for employees, the honesty and integrity of the testing program, and cooperation with or provision of information to DOT agency representatives. Many of the items are drawn from problems the Department has noted under the existing Part 40.
We note that the PIE provisions of the rule are not intended to have retroactive effect. That is, the Department would not initiate a PIE proceeding on the basis of conduct that occurred before the PIE provisions took effect.

§40.367 Who initiates a PIE proceeding?
§ 40.369 What is the discretion of an initiating official in starting a PIE proceeding?
§40.371 On what information does an initiating official rely in deciding whether to start a PIE proceeding?
§40.411 What is the role of the DOT Inspector General’s office?
These sections concern the Department’s decision about whether to begin a PIE proceeding. Only selected DOT officials are authorized to begin such a proceeding: DOT agency drug and alcohol program managers, an official of ODAPC other than the Director (who, as the decisionmaker, is precluded from any role in initiating or prosecuting a PIE proceeding), or the designee of these officials. We emphasize that individual inspectors and subordinate staff members, while they may provide information to initiating officials, are not themselves authorized to initiate PIE proceedings.
Initiating officials have broad discretion in deciding whether to start a PIE proceeding, though this discretion must be exercised with the policy expressed §40.365 in mind. DOT is never required to start a PIE proceeding. An initiating official can take into account such factors as his or her judgment of the seriousness of the matter and the availability of resources to investigate and prosecute a matter adequately.
An initiating official can rely on credible information from any source in deciding whether to start a proceeding. As many commenters requested, the initiating official will make an informal contact with the service agent before sending a correction notice, in an attempt to determine if the service agent has any information that would help the initiating official make his or her decision to initiate a proceeding.
While the DOT inspector general (IG) is not an initiating official in the PIE process, the IG can investigate complaints concerning waste, fraud, and abuse in the drug and alcohol testing program. The initiating official can use information from IG investigations and audits as the basis to begin a PIE proceeding. The IG can also take action leading to criminal or civil action against a service agent or employer if the facts warrant.

§40.373 Before starting a PIE proceeding, does the initiating official give the service agent an opportunity to correct problems?
§40.375 How does the initiating official start a PIE proceeding?
These sections describe the first formal steps in any PIE proceeding. Before taking other action, the initiating official sends a correction notice, outlining the compliance problem and giving the service agent 60 days to correct it. If the service agent documents correction of the problem in this period, the official does not pursue a PIE proceeding. If not, the official sends a notice of proposed exclusion (NOPE) to the service agent, detailing the basis for the proposed exclusion and informing the service agent of the next procedural steps.
There may be some problems that cannot be corrected, or some misconduct so serious that subsequent corrective steps are insufficient to make up for the effects of noncompliance. For example, an MRO who has counterfeit medical credentials probably cannot correct this problem. A laboratory that has demonstrated a significant lack of business integrity by falsifying evidence or a pattern or practice of careless conduct resulting in the cancellation of numerous tests might have great difficulty demonstrating that it has made adequate changes to make up for the problems it caused. The Department is not limited, in deciding whether to initiate a PIE proceeding, to purely prospective considerations (e.g., analogous to the “imminent [future] harm” standard HHS uses in deciding to take certification action against a laboratory). Nor is the Department required to accept, on face value, assurances from a service agent that it has learned its lesson and will comply in the future. The Department will make judgments of this kind on a case-by-case basis.

§40.377 Who decides whether to issue a PIE?
This sections focuses on the role of the ODAPC Director as decisionmaker. Section §40.377 articulates the firewall between the Director and the initiating official, to ensure impartiality. The Director can delegate the decisionmaking role to another official (e.g., in a case where the Director would be unavailable to decide the case or recused himself or herself because of a potential conflict of interest), who would then be subject to the same firewall requirements.

§40.379 How do you contest the issuance of a PIE?
§40.381 What information do you present to contest the proposed issuance of a PIE?
§40.383 What procedures apply if you contest the issuance of a PIE?
§40.385 Who bears the burden of proof in a PIE proceeding?
These sections cover an important part of the administrative due process protections built into the PIE provisions of the rule. Within 30 days of getting a NOPE, a service agent must contact the Director and make arrangements to present information and arguments. If the service agent asks to meet with the Director, the Director will schedule a meeting. At this meeting, or in a written presentation, the service agent may provide any arguments or factual information it believes relevant to the proposed issuance of a PIE, its scope and duration. We emphasize that the opportunity to meet with the Director is not a “hearing” or “trial,” with formal rules of evidence. The Director will consider any relevant evidence and listen to any witnesses the initiating official or the service agent presents. Because the initiating official is the proponent of the PIE action, he or she bears the burden of proof (by a preponderance of the evidence) on all issues. To justify issuing a PIE, the Director must find that the service agent failed or refused to perform drug and/or alcohol testing services as required by this part or is in serious noncompliance with a DOT agency drug and alcohol regulation.

§40.387 What matters does the Director decide concerning a proposed PIE?
§40.389 What factors may the Director consider?
§40.391 What is the scope of a PIE?
§40.393 How long does a PIE stay in effect?
§40.407 May a service agent ask to have a PIE reduced or terminated?
These sections concern what decisions the Director makes and which factors the Director considers in deciding on whether to issue a PIE, as well as the scope and duration of a PIE. When the Director receives the NOPE and the service agent’s response to it, the Director can dismiss the proceeding (e.g., for not raising a sufficiently serious noncompliance issue to warrant issuing a PIE), remand it to the initiating official for more fact finding, or continue with the proceeding. Whenever a proceeding does go to decision, the Director would make determinations concerning disputed factual issues, whether the facts support issuing a PIE, and the scope and duration of a PIE. The factors the Director considers in making these decisions include the seriousness of the noncompliance, the pervasiveness of the noncompliance within the service agent’s organization, and the compliance disposition of the service agent.
The scope of a PIE was the subject of many comments. In the final rule, the initiating official proposes a scope for the PIE, the service agent can contest the proposal, and the Director decides what the scope should be. The general rule is that a PIE applies to parts of an organization or types of services that are affected by the service agent’s noncompliance. The more pervasive the misconduct, the broader the scope of the PIE. The rule text provides several examples of the Department’s thinking on how to view the proper scope of a PIE.
There are also situations in which the PIE can apply to individual officers or employees of the service agent, if they are responsible for the noncompliance that formed the basis for the PIE. This provision is intended to prevent individuals from going into business under a different business or corporate name while a PIE remains in effect against the service agent they worked for. The same is true of businesses affiliated with the service agent concerning which the Department issued a PIE.
A PIE stays in effect from one to five years. Like the scope of a PIE, the duration of a PIE is proposed by the initiating official, may be contested by the service agent, and is decided upon by the ODAPC Director. The Director’s decision is based on such factors as the seriousness of the noncompliance on which the PIE is based and the continued need to protect employers and employees from the service agent’s noncompliance. The Director considers factors such as those listed in §40.387 in making this decision.
After a PIE has been in effect for nine months, the service agent can apply to have its duration shortened. If the Director verifies that the sources of noncompliance have been eliminated and that all drug or alcohol testing-related services the service agent would provide to DOT-regulated employers will be consistent with the requirements of this part, the Director may issue a notice terminating or reducing the PIE. We emphasize that this process is limited to the issues of duration and scope: it is not an appeal or reconsideration of the decision to issue the PIE.

§40.395 Can you settle a PIE proceeding?
§40.397 When does the Director make a PIE decision?
§40.399 How does the Department notify service agents of its decision?
§40.401 How does the Department notify employers and the public about a PIE?
§40.403 Must a service agent notify its clients when the Department issues a PIE?
§40.405 May the Federal courts review PIE decisions?
§40.413 How are notices sent to service agents?
The next group of provisions concern the mechanics of making PIE decisions and informing people about them. The initiating official and the service agent can settle a PIE proceeding at any time before the Director issues a decision. The Director must concur in the settlement, which could include, for example, provisions to ensure compliance or a period of voluntary exclusion during which the service agent agrees not to provide certain services to DOT-regulated employers while it fixes noncompliance problems.
The Director is normally responsible for making a decision within 60 days of the record of the proceeding being completed. The Director can extend this normal decision period for 30 days at a time for good cause. It is the Department’s policy to expedite these important decisions, however. Once the Director issues a decision, it is a final administrative action of the Department, subject, like all such actions, to judicial review under the Administrative Procedure Act.
The Director must provide written notice of a PIE to the service agent, including a statement of the basis for his or her decision and the scope and duration of the PIE. The Department also informs the public about the PIE though a web site posting and a Federal Register notice. We also anticipate informing employer and testing industry groups about the action, so that they can inform their members. The service agent also has an affirmative responsibility to inform customers about the PIE, so that they can obtain services from and transfer records to other service agents. Finally, §40.113 concerns the mechanics of how notices are sent to service agents and when they are deemed to have been received. As a policy matter, the initiating official will make reasonable efforts to follow up with the service agent to ensure that the service agent has received and understood the notice.

§40.409 What does the issuance of a PIE mean to transportation employers?
Employers have an affirmative responsibility to stop using the services of a service agent that is subject to a PIE. This obligation begins 90 days after the Director issues the PIE, to give the employer time to find another service provider. The obligation applies to services provided through an affiliate of the service agent subject to the PIE as well as the service agent itself, and it applies to employers in all DOT-regulated industries. It is important to note that a PIE does not invalidate otherwise proper drug and alcohol tests in which the service agent was involved before, and for 90 days after, the issuance of the PIE. The rule text spells out the operation of this provision in more detail.

Appendices
Appendix A

During the last decade of drug testing, the Department has not regulated nor standardized the materials (i.e., collection containers, specimen bottles, etc.) used in DOT-mandated drug testing. During the first few years of drug testing, only one specimen bottle was required. Subsequent to the Omnibus Act, split specimen collections became a requirement for four of the six DOT agencies. In general, each laboratory provided to the collection site or the employer laboratory specific collection kits, many of which differed in composition.
The introduction of the split, the fact that in the pipeline and maritime industry split collection was an employer option, and the wide variance among the laboratories’ kits, resulted in significant problems and numerous tests had to be cancelled based on collector error that, at times, was due to the differences in the makeup of the kits.
Several years ago, the Department requested all laboratories to provide samples of their urine collection kits. These were reviewed against the then current regulatory requirements (e.g., tamper-evident seals on the bottles, availability and use of shipping container seals, collection instructions), and a majority of kits did not meet the regulatory requirements. Laboratories were notified and corrective action was recommended, but the Department did not take any specific action to standardize these kits at that time.
The Department is convinced that the new requirement for all DOT agencies to use splits, and the development of a standard kit, will result in fewer mistakes and cancellations of drug tests. In that light, Appendix A spells out broad criteria for the composition of urine collection kits.
The requirement for a collection container should minimize the need to give the employee both bottles, when there is no collection container in the kit, and request the employee to urinate into only one bottle. In some cases, employees fill both bottles and collectors submit these, resulting in splits that do not reconfirm. In some cases, the two bottles contained urine of different colors, but collectors submitted them anyway.
The requirement that the collection container and the bottles be wrapped or sealed in a plastic bag was established earlier to prevent accusations by the employee that either the collector or someone at the collection site introduced some foreign substance into the containers, causing a positive result. The standards specifically spell out that the collection container needs to be securely wrapped separately from the specimen bottles and that the bottles must be either shrink wrapped or sealed in plastic bags or may be secured with other methodology provided that the tamper-evident mechanism is effective and easily discernable to the employee.
For example, the use of a tiny filament between the bottle and the cap which breaks when the bottle is first opened may be effective in determining if the bottle was opened, but only if the employee has this pointed out to him or her. Even at that, the employee would have to look very closely to see if the filament is or is not attached. Most collectors will not spend the time to go through this process and employees can say they were not really able to tell if the filament was in place. It is much easier to defend and remember that a bottle was wrapped in a plastic bag, rather than argue that the employee was or was not specifically shown the filament or that he or she actually did or did not see the filament. Conversely, a bottle that has a paper label
The use of a leak-resistant plastic bag has been in place for a number of years, driven primarily by U.S. Postal Service and courier and shipping services requirements as a safety issue related to transportation of biological specimens. Under the new standards, the plastic bags must not only be leak-resistant (no zip locked bags), but must also be tamper-evident. In other words, once the bag is sealed it cannot be opened without the opening becoming obvious.
Under current rules, there is a requirement that the shipping container be sealed with a shipping container seal that is initialed or signed and dated by the collector. In the NPRM, we proposed to use a tamper-evident seal on the plastic bag instead of the shipping container, since in many cases, collectors may collect several specimens in plastic bags and hold or store them until they have several which can then be placed into a shipping contained which is subsequently sealed. There were few comments related to the kit, but laboratories did indicate that when a shipping container, usually a box, arrives at the laboratory with a broken seal, the specimens are tested provided the specimen bottle seals are intact. To date, the Department is not aware of any problems related to this practice. However, it does call into question the purpose of the second (shipping container) seal. The Department’s position is that if the leak-resistant plastic bag is tamper-evident, that serves as the secondary protection, which is currently ensured by the shipping seal.
The primary concern is, and always has been, the integrity of the specimen bottle seals. As long as the integrity of the specimen bottle seals is intact, the condition of the shipping container seal is not relevant. The standards listed in Appendix A, therefore, do not include a requirement for a shipping container or plastic bag seal.
The current regulatory requirement is that the “specimens shall be placed in shipping containers designed to minimize the possibility of damage during shipment (e.g., specimen boxes and/or padded mailers)”. In many cases, kits contain cardboard boxes designed to hold only two bottles for shipment. In some cases, collection sites may, and do, place a number of specimens in plastic bags and then into one large shipping container or box, and transport the specimens in that manner. With the advent of stronger plastics, some laboratories are requesting collection sites to transport bottles wrapped in leak-resistant plastic bags which are placed into larger plastic envelopes, contending that because the specimen bottles are constructed of stronger plastic, this is an acceptable practice.
The Department has discussed this issue of transporting specimens with two of the largest courier services and both have expressed their concerns about leakage of urine specimens in transit and concern for the safety of their employees. Both courier services require a watertight primary receptacle (bottle) and a secondary watertight container, which in this case would be the leak-resistant plastic bag. One courier requires a sturdy outer package consisting of corrugated fiberboard, wood, metal, or rigid plastic; Styrofoam boxes, plastic bags, and paper envelopes are not acceptable as outer packaging. The second major courier requires that the primary container (bottle) meet a 150-pound crush test. If it meets that test, it may be placed in a leak-resistant plastic bag or container and then may be placed in a secondary leak-resistant plastic envelope without further packaging. Conversely, if the bottle(s) does not meet the crush test, it must be placed into a secondary package, which meets the 150-pound crush test. The secondary package may then be placed into a plastic shipping envelope.
The Department has determined that current shipping regulations and requirements are sufficient to ensure that specimens are shipped in a manner that will protect them from damage. Therefore, the standards direct that the specimen bottles be shipped in containers that can sufficiently protect them from damage; the standards do not specify the type of material or the extent of weight (crush test) that the shipping containers should meet. The standards also permit the specimens to be transported to a laboratory in the leak-resistant plastic bag provided they are hand-carried by a laboratory courier. In other words, the courier picks the specimens up in whatever is a convenient shipping or carrying container and does not subsequently place them into a system (automated transportation, another delivery courier, or on a plane, railroad, or truck), but personally delivers them to the laboratory.

Appendix B
Appendix B is simply a list of the data elements and format for the semi-annual laboratory report provided to employers. Laboratories should follow this format when they compose these reports.

Appendix D
This appendix identifies the format and type of information that the MRO needs to submit to DOT when a split specimen test fails to reconfirm the presence of the drug/drug metabolite, adulterant, or the substitution finding found in the primary specimen.
There has been a long-standing practice under the current rule that when the employee requests a test of the split specimen and the test of the split fails to reconfirm the presence of the drug/drug metabolite that was found in the primary specimen, or if the split was not available (i.e., not collected or leaked in transit), the MRO was required to report this result to the Department. The purpose of this report was to determine if this was an administrative or collection error (e.g., the primary bottle and the split bottle were not the same urine) or if the failure to reconfirm was one of a technical nature, requiring review by HHS. Although the majority of “failures to reconfirm” have been due to the unavailability of the split specimen, some of the technical problems led to the discovery of the various adulterants that are currently used to circumvent the testing process. Based on this, the Department will continue to require this reporting by the MRO.
The Department has also decided to permit an employee to request the test of the split specimen when the primary specimen is reported as adulterated or substituted. Based on that decision, we have determined that should the split fail to indicate the adulterant or the substitution is not supported by the test of the split or the MRO cancels the test based on medical evidence, the MRO needs to report this cancellation to the Department in the same manner as if it was a positive result which failed to reconfirm.
There is not a standard “report” that the MRO needs to fill out. However, for consistency of information, Appendix D provides the format for the information that the Department needs to fully assess if there are any technical problems in the testing process. For ease of use, the same format can be used for reporting cancellation of a positive as well as for adulteration and substitution.

Appendix E
This Appendix lists the 12 criteria the Department examines in determining whether certification organizations should be accepted under §§40.281 – 40.283 for participation in the SAP program. The first eleven items are the same criteria the Department has used in evaluating other certification organizations that are already part of the program (e.g., ICRC). The twelfth item is NCCA accreditation, discussed in the preamble to §40.281.
Appendix F
This Appendix is a list of the drug and alcohol testing information transmission functions that C/TPAs are authorized to perform (see §40.345) C/TPAs may, acting as an intermediary, transmit the information in the listed regulatory sections to the DER for an employer, if the employer chooses to have the C/TPA do so. These are the only items that C/TPAs are permitted to transmit to the employer as an intermediary. The use of service agent intermediaries is prohibited in all other cases, such as transmission of laboratory drug test results to MROs, the transmission of SAP reports to employers, and the transmission of positive alcohol test results.
In every case, the C/TPA must ensure that, in transmitting the information, it meets all requirements (e.g., concerning confidentiality and timing) that would apply if the party originating the information (e.g., an MRO or collector) sent the information directly to the employer. For example, if a C/TPA transmits MROs’ drug testing results to DERs, you must transmit each drug test result to the DER in compliance with the requirements for MROs set forth in §40.157.

Appendix G
The ATF included in Appendix G is a slight modification of the existing alcohol testing form. One commenter suggested that a new alcohol testing form be developed that incorporated requirements proposed by the NPRM (e.g., the name of the DER, whether an STT used a saliva device). We believe that a revised form will serve the program better by allowing us to capture the necessary information. At the same time, it will no longer require the employee to sign in Step 4 if the alcohol concentration is less than 0.02. This signature will only be necessary if the alcohol concentration is 0.02 or higher on the confirmation test. Consistent with the CCF, all pages of the form may be white, with the distribution legend at the bottom of pages 2 and 3 following the colors of the current form. The OMB control number of the new form will be OMB 2105-0529, the same as for the current form. Program participants may start using the form [insert date 30 days from the date of publication]. Use of the form will become mandatory on August 1, 2001.

Regulatory Analyses and Notices
Executive Order 12866 and DOT Regulatory Policies and Procedures
This rule is a significant rule for purposes of Executive Order 12866. It is significant because of its policy importance and its impact upon sizeable industries. It is not, however, an economically significant regulation. It is a reworking of existing requirements, imposing few new mandates, and should not have significant incremental costs. Because of its multimodal impact and policy interest to regulated parties and service agents, it is a significant rule for purposes of the DOT Regulatory Policies and Procedures. Throughout this regulation, we have attempted to balance the costs of new requirements with the cost savings accrued through the elimination of some current requirements.

Economic Impacts
There are two features of the regulation that would add new requirements having economic impacts. The first is the requirement for validity testing. As the result of work by HHS and the laboratories, these protocols are already in place and are being used by most laboratories, so we expect the incremental costs of this requirement to be modest. The Department believes that public safety is well-served by these steps to identify and hold accountable employees in safety-sensitive positions who attempt to tamper with the testing process.
Second, the rule includes additional training requirements for some service agents. Errors in the testing process resulting from lack of training can lead to increased employer program costs and increased paperwork required to document the errors and repeat the testing process. The rule upgrades requirements for collectors, MROs, and SAPs. Well-attended training courses for MROs already exist, as do some collector and SAP courses.
At the same time, the Department anticipates cost savings from some provisions of the regulation, such as the reductions in blind specimen requirements and mitigation of some reporting requirements. The additional training requirements discussed in the previous paragraphs will help to reduce costs from errors in the system. For example, every time a better-trained collector conducts a collection properly instead of making a mistake, the costs of developing memorandums for correction, preparing laboratory litigation packages, arbitration or court proceedings, and reversing personnel actions are avoided.
The Department has estimated cost increases and decreases that could be expected if the proposed rule’s provisions are made final. It is important to understand that this is a big program, touching some 8.34 million employees working for about 673,413 employers. Around 30,000 individuals and organizations work as service agents.
In terms of new costs, the Department estimates an annual cost of about $1.4 million for validity testing. With respect to training for SAPs. MROs, BATs, STTs, and collectors, we anticipate that annual costs will run about $4 million. In addition, we estimate that there will be one-time costs for a variety of administrative requirements in the first year of implementation of approximately $1.93 million.
On the other hand, we anticipate saving at least $4.3 million per year from the reduction in blind specimen testing (the savings will probably be somewhat greater, because fewer organizations will be required to submit blind specimens). By changing the current quarterly laboratory report requirement to require a semiannual report, we anticipate saving another $2.5 million annually. By permitting positive, adulterated, and substituted test results to be faxed rather than sent by overnight express, we project an annual $3.3 million saving. These annual savings are greater than the additional annual costs we anticipate for the proposed rule. In total, then, we estimate that the new rule will result in about $7.4 million in incremental costs versus $10.1 million in incremental savings, compared to the existing rule.
The Department has placed in the docket for this rulemaking a document describing the basis for these estimates in greater detail.

Executive Order 13132 and Federalism
This final rule does not have sufficient Federalism impacts to warrant further action under Executive Order 13132. The Department notes that the provisions of Part 40 are incorporated by reference in the other DOT agency drug and alcohol testing regulations, which have existing pre-emption provisions in them. Consequently, for example, a provision of a state or local law or regulation that conflicted with a provision of Part 40 could be subject to pre-emption on the basis of this existing operating administration authority.

Regulatory Flexibility Act
With respect to the Regulatory Flexibility Act, the Department certifies that this rule does not have a significant economic impact on a substantial number of small entities, so a Regulatory Flexibility analysis has not been prepared. It is clear that the rule affects large numbers of small entities. Many thousands of covered employers are small businesses (e.g., small trucking companies, small transit authorities), as are many service agents (e.g., occupational health clinics). Given the small, and overall favorable, net change in regulatory costs compared to the present rule, spread over these thousands of small entitites, the cost impact per entity is expected to be negligible.
We have also taken some steps, such as the reduction in blind specimens, the reduced frequency of some reports, and the discretion we have given C/TPAs to act as intermediaries in some situations, that should assist small entities in complying and reduce their burdens. The PIE provision should reduce costs to small employers as the result of noncompliance by service agents. Our ability to create special provisions for small entities is limited by the need to have uniform requirements to ensure safety and fairness to employees. There must be a single standard for the accuracy and integrity of the program and the protection of legitimate employee interests that cannot vary with the size of the employer or service agent.
This rulemaking resulted from a “610 Review” under the Regulatory Flexibility Act. We have reviewed the existing program to identify areas in which the rule can be improved with the effect of assisting small businesses to comply in a rational and cost-effective manner. In addition to the general clarification of the program this rule provides, we have identified some specific areas (e.g., blind specimen requirements, the addition of the public interest exclusion provision, the reduction in reporting frequencies, the discretionary use of C/TPAs to transmit information) that should be particularly helpful to small regulated employers.

Paperwork Reduction Act
Since the inception of the Department’s drug and alcohol testing program, each individual DOT agency has complied with the requirements of the Paperwork Reduction Act (PRA) by submitting a justification to the Office of Management and Budget (OMB). These PRA submissions reflected requirements derived from the respective DOT agency drug and alcohol regulations as well as from Part 40. The submissions were never presented to OMB in a coordinated fashion, nor were they reviewed together to ensure that all drug and alcohol program requirements were reflected in a manner that was consistent, accurate, and non-duplicative.
In January 2000, the Department began an effort to evaluate prior PRA submissions in an attempt to address disparities between DOT agency estimates as well as the aggregate burden and cost estimates. A One-DOT group was formed. Its goals were to bring consistency and simplicity to DOT’s PRA submissions; eliminate PRA submission duplication between and among DOT agencies, OST, and other Federal agencies; eliminate PRA submission discrepancies; and, more importantly perhaps, ensure accuracy of submissions. In addition, the group decided to standardize cost, hour, and wage indicators, where possible, and to identify task commonalities in DOT agency regulations and standardize how they are reported to OMB. The group sought to determine where program PRA responsibilities for specific drug and alcohol program elements lie – with the DOT agencies, OST, or other Federal agencies.
The group identified a total of 37 PRA tasks contained in one or more of the regulations of six DOT agencies (i.e., that properly reside in the operating administration rules rather than in Part 40). Some tasks were shared by all or some DOT agencies, while other tasks were peculiar to only one DOT agency. The operating administrations subsequently made PRA submissions to OMB for these items, which OMB approved. These submissions resulted in a reduction in the paperwork burden attributable to operating administration rules, both because Part 40-related burdens were kept separate and because a significant overestimate of the burden connected with one of the operating administration programs was corrected. The total reduction was over 50 million hours.
Next, the Department constructed a baseline for the information collection burden attributable to the existing Part 40 (most of which had not previously been accounted for in PRA submissions or had been subsumed under operating administration submissions). This baseline is approximately 2.23 million hours, The Department submitted a PRA request to OMB concerning this material, which OMB has approved.
Third, the Department compared the information collection burden of the existing Part 40 baseline to the estimated burden for the new Part 40. Comparing the existing rule to the new rule, there are some items that increase (e.g., obtaining test results from previous employers, MRO review of negative test documentation, employer SAP lists being provided to employees), in part because they previously were accounted for under operating administration rules. Other items decreased (e.g., changing from quarterly to semi-annual laboratory reports). The largest decrease resulted from the drug testing form’s burden hours being accounted for under the PRA responsibility of HHS. Cumulatively, the new Part 40’s information collection burden is approximately about 842 thousand hours, or about 1.39 million hours less than that of the existing Part 40.
For informational purposes, the Department has placed its entire Paperwork Reduction Act package on the internet, on the same Docket Management System web site on which comments on this rulemaking are posted. Interested persons may review this material electronically. The following web address provides instructions and access to the DOT electronic docket: http://dms.dot.gov/search/. To find the material on the Part 40 rulemaking, just enter the number 6578 in the “docket number” search dialog box.
In addition, we note that §40.25, which requires employers to obtain information from applicants about previous drug and alcohol test results, was not previously the subject of PRA-related comment. While this section is part of the PRA package OMB has approved in connection with Part 40, you may comment about the information collection aspects of the section. Please send any comments to Jim L. Swart, Drug and Alcohol Policy Advisor, Office of Drug and Alcohol Policy and Compliance (ODAPC), 400 7th Street, SW., Room 10403, Washington DC, 20590, 202-366-3784 (voice), 202-366-3897 (fax), or jim.swart@ost.dot.gov (e-mail).

Other Executive Orders
There are a number of other Executive Orders that can affect rulemakings. These include Executive Orders 13084 (Consultation and Coordination with Indian Tribal Governments), 12988 (Civil Justice Reform), 12875 (Enhancing the Intergovernmental Partnership), 12630 (Governmental Actions and Interference with Constitutionally Protected Property Rights), 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations), 13045 (Protection of Children from Environmental Health Risks and Safety Risks), and 12889 (Implementation of North American Free Trade Agreement). We have considered these Executive Orders in the context of this rule, and we believe that the rule does not directly affect the matters that the Executive Orders cover. We have prepared this rulemaking in accordance with the Presidential Directive on Plain Language.

List of Subjects in 49 CFR Part 40
Administrative practice and procedures, Alcohol abuse, Alcohol testing, Drug abuse, Drug testing, Laboratories, Reporting and recordkeeping requirements, Safety, Transportation.

ISSUED THIS 1st DAY OF December 2000, AT WASHINGTON, DC

_______________________
Rodney E. Slater
Secretary of Transportation

For the reasons set forth in the preamble, the Department of Transportation amends 49 CFR subtitle A as follows:
1. Effective [insert DATE 30 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER], amend the current 49 CFR Part 40 as follows:

PART – 40 [AMENDED]
a. The authority citation for Part 40 is revised to read as follows:
Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 45101 et seq.

b. Add Subparts E and F to read as follows:

Subpart E – Additional Administrative Provisions and Validity Testing

Sec.
40.201 Additional definitions.
40.203 Who issues authoritative interpretations of this regulation?
40.205 What is validity testing, and are laboratories authorized to conduct it?
40.207 What validity tests must laboratories conduct on primary specimens?
40.209 What criteria do laboratories use to establish that a specimen is dilute or substituted?
40.211 What criteria do laboratories use to establish that a specimen is adulterated?
40.213 How long does the laboratory retain specimens after testing?
40.215 On what basis does the MRO verify test results involving adulteration or substitution?
40.217 What does the second laboratory do with the split specimen when it is tested to reconfirm an adulterated test result?
40.219 What does the second laboratory do with the split specimen when it is tested to reconfirm a substituted test result?
40.221 What information do laboratories report to MROs regarding split specimen results?
40.223 What does the MRO do with split specimen laboratory results?
40.225 What is a refusal to take a DOT drug test, and what are the consequences?

Subpart F – Public Interest Exclusions

40.301 – 40.359 [Reserved]
40.361 What is the purpose of a public interest exclusion (PIE)?
40.363 On what basis may the Department issue a PIE?
40.365 What is the Department’s policy concerning starting a PIE proceeding?
40.367 Who initiates a PIE proceeding?
40.369 What is the discretion of an initiating official in starting a PIE proceeding?
40.371 On what information does an initiating official rely in deciding whether to start a PIE proceeding?
40.373 Before starting a PIE proceeding, does the initiating official give the service agent an opportunity to correct problems?
40.375 How does the initiating official start a PIE proceeding?
40.377 Who decides whether to issue a PIE?
40.379 How do you contest the issuance of a PIE?
40.381 What information do you present to contest the proposed issuance of a PIE?
40.383 What procedures apply if you contest the issuance of a PIE?
40.385 Who bears the burden of proof in a PIE proceeding?
40.387 What matters does the Director decide concerning a proposed
PIE?
40.389 What factors may the Director consider?

40.391 What is the scope of a PIE?
40.393 How long does a PIE stay in effect?
40.395 Can you settle a PIE proceeding?
40.397 When does the Director make a PIE decision?
40.399 How does the Department notify service agents of its decision?
40.401 How does the Department notify employers and the public about a PIE?
40.403 Must a service agent notify its clients when the Department issues a PIE?
40.405 May the Federal courts review PIE decisions?
40.407 May a service agent ask to have a PIE reduced or terminated?
40.409 What does the issuance of a PIE mean to transportation employers?
40.411 What is the role of the DOT Inspector General’s office?
40.413 How are notices sent to service agents?

SUBPART E – Additional Administrative Provisions and Validity Testing
§40.201 Additional definitions.
The following definitions apply to the provisions of this subpart E and subpart F of this part:
Adulterated specimen. A specimen that contains a substance that is not expected to be present in human urine, or contains a substance expected to be present but is at a concentration so high that it is not consistent with human urine.
Affiliate. Persons are affiliates of one another if, directly or indirectly, one controls or has the power to control the other, or a third party controls or has the power to control both. Indicators of control include, but are not limited to: interlocking management or ownership; shared interest among family members; shared facilities or equipment; or common use of employees. Following the issuance of a public interest exclusion, an organization having the same or similar management, ownership, or principal employees as the service agent concerning whom a public interest exclusion is in effect is regarded as an affiliate. This definition is used in connection with the public interest exclusion procedures of Subpart F of this part.
Confirmation (or confirmatory) validity test. A second test performed on a urine specimen to further support a validity test result.
Dilute specimen. A specimen with creatinine and specific gravity values that are lower than expected for human urine.
Initial validity test. The first test used to determine if a specimen is adulterated, diluted, or substituted.
Office of Drug and Alcohol Policy and Compliance (ODAPC). The office in the Office of the Secretary, DOT, that is responsible for coordinating drug and alcohol testing program matters within the Department and providing information concerning the implementation of this part.
Split specimen. In drug testing, a part of the urine specimen that is sent to a first laboratory and retained unopened, and which is transported to a second laboratory in the event that the employee requests that it be tested following a verified positive test of the primary specimen or a verified adulterated or substituted test result.
Substituted specimen. A specimen with creatinine and specific gravity values that are so diminished that they are not consistent with human urine.

§40.203 Who issues authoritative interpretations of this regulation?
ODAPC and the DOT Office of General Counsel (OGC) provide written interpretations of the provisions of this part. These written DOT interpretations are the only official and authoritative interpretations concerning the provisions of this part. DOT agencies may incorporate ODAPC/OGC interpretations in written guidance they issue concerning drug and alcohol testing matters.

§40.205 What is validity testing, and are laboratories authorized to conduct it?
(a) Specimen validity testing is the evaluation of the specimen to determine if it is consistent with normal human urine. The purpose of validity testing is to determine whether certain adulterants or foreign substances were added to the urine, if the urine was diluted, or if the specimen was substituted.
(b) As a laboratory, you are authorized to conduct validity testing.

§40.207 What validity tests must laboratories conduct on primary specimens?
As a laboratory, if you conduct validity testing under the authorization of §40.205(b), you must conduct it in accordance with the requirements of this section.
(a) You must test each primary specimen for creatinine. You must also determine its specific gravity if you find that the creatinine concentration is less than 20 mg/dL.
(b) You must measure the pH of each primary specimen.
(c) You must test each primary specimen to determine if it contains substances that may be used to adulterate the specimen. Your tests must have the capability of determining whether any substance identified in current HHS requirements or specimen validity guidance is present in the specimen.
(d) If you suspect the presence of an interfering substance/adulterant that could make a test result invalid, but you are unable to identify it (e.g., a new adulterant), you may, as the first laboratory, send the specimen to another HHS certified laboratory that has the capability of doing so.
(e) If you identify a substance in a specimen that appears to be an adulterant, but which is not listed in current HHS requirements or guidance, you must report the finding in writing to ODAPC and the Division of Workplace Programs, HHS, within three business days. You must also complete testing of the specimen for drugs, to the extent technically feasible.
(f) You must conserve as much as possible of the specimen for possible future testing.

§40.209 What criteria do laboratories use to establish that a specimen is dilute or substituted?
(a) As a laboratory you must consider the primary specimen to be dilute if the creatinine concentration is less than 20 mg/dL and the specific gravity is less than 1.003, unless the criteria for a substituted specimen are met.
(b) As a laboratory you must consider the primary specimen to be substituted if the creatinine concentration is less than or equal to 5 mg/dL and the specific gravity is less than or equal to 1.001 or greater than or equal to 1.020.

§40.211 What criteria do laboratories use to establish that a specimen is adulterated?
(a) As a laboratory, you must consider the primary specimen to be adulterated if you determine that –
(1) A substance that is not expected to be present in human urine is identified in the specimen;
(2) A substance that is expected to be present in human urine is identified at a concentration so high that it is not consistent with human urine; or
(3) The physical characteristics of the specimen are outside the normal expected range for human urine.
(b) In making your determination under paragraph (a) of this section, you must apply the criteria in current HHS requirements or specimen validity guidance.

§40.213 How long does the laboratory retain specimens after testing?
(a) As a laboratory testing the primary specimen, you must retain a specimen that was reported with positive, adulterated, substituted, or invalid results for a minimum of one year.
(b) You must keep such a specimen in secure, long-term, frozen storage in accordance with HHS requirements.
(c) Within the one-year period, the MRO, the employee, the employer, or a DOT agency may request in writing that you retain a specimen for an additional period of time (e.g., for the purpose of preserving evidence for litigation or a safety investigation). If you receive such a request, you must comply with it. If you do not receive such a request, you may discard the specimen at the end of the year.
(d) If you have not sent the split specimen to another laboratory for testing, you must retain the split specimen for an employee’s test for the same period of time that you retain the primary specimen and under the same storage conditions.
(e) As the laboratory testing the split specimen, you must meet the requirements of paragraphs (a) through (c) of this section with respect to the split specimen.

§40.215 On what basis does the MRO verify test results involving adulteration or substitution?
(a) As an MRO, when you receive a laboratory report that a specimen is adulterated or substituted, you must treat that report in the same way you treat the laboratory’s report of a confirmed positive test for a drug or drug metabolite.
(b) You must follow the same procedures used for verification of a confirmed positive test for a drug or drug except as otherwise provided in this section.
(c) In the verification interview, you must explain the laboratory findings to the employee and address technical questions or issues the employee may raise.
(d) You must offer the employee the opportunity to present a legitimate medical explanation for the laboratory findings with respect to presence of the adulterant in, or the creatinine and specific gravity findings for, the specimen.
(e) The employee has the burden of proof that there is a legitimate medical explanation.
(1) To meet this burden in the case of an adulterated specimen, the employee must demonstrate that the adulterant found by the laboratory entered the specimen through physiological means.
(2) To meet this burden in the case of a substituted specimen, the employee must demonstrate that he or she did produce or could have produced urine, through physiological means, meeting the creatinine and specific gravity criteria of §40.209(b).
(3) The employee must present information meeting this burden at the time of the verification interview. As the MRO, you have discretion to extend the time available to the employee for this purpose for up to five days before verifying the specimen, if you determine that there is a reasonable basis to believe that the employee will be able to produce relevant evidence supporting a legitimate medical explanation within that time.
(f) As the MRO or the employer, you are not responsible for arranging, conducting, or paying for any studies, examinations or analyses to determine whether a legitimate medical explanation exists.
(g) As the MRO, you must exercise your best professional judgment in deciding whether the employee has established a legitimate medical explanation.
(1) If you determine that the employee’s explanation does not present a reasonable basis for concluding that there may be a legitimate medical explanation, you must report the test to the DER as a verified refusal to test because of adulteration or substitution, as applicable.
(2) If you believe that the employee’s explanation may present a reasonable basis for concluding that there is a legitimate medical explanation, you must direct the employee to obtain, within the five-day period set forth in paragraph (e)(3) of this section, a further medical evaluation. This evaluation must be performed by a licensed physician (the “referral physician”), acceptable to you, with expertise in the medical issues raised by the employee’s explanation. (The MRO may perform this evaluation if the MRO has appropriate expertise.)
(i) As the MRO or employer, you are not responsible for finding or paying a referral physician. However, on request of the employee, you must provide reasonable assistance to the employee’s efforts to find such a physician. The final choice of the referral physician is the employee’s, as long as the physician is acceptable to you.
(ii) As the MRO, you must consult with the referral physician, providing guidance to him or her concerning his or her responsibilities under this section. As part of this consultation, you must provide the following information to the referral physician:
(A) That the employee was required to take a DOT drug test, but the laboratory reported that the specimen was adulterated or substituted, which is treated as a refusal to test;
(B) The consequences of the appropriate DOT agency regulation for refusing to take the required drug test;
(C) That the referral physician must agree to follow the requirements of paragraphs (g) (3) through (g) (4) of this section; and
(D) That the referral physician must provide you with a signed statement of his or her recommendations.
(3) As the referral physician, you must evaluate the employee and consider any evidence the employee presents concerning the employee’s medical explanation. You may conduct additional tests to determine whether there is a legitimate medical explanation. Any additional urine tests must be performed in an HHS-certified laboratory.
(4) As the referral physician, you must then make a written recommendation to the MRO about whether the MRO should determine that there is a legitimate medical explanation. As the MRO, you must seriously consider and assess the referral physician’s recommendation in deciding whether there is a legitimate medical explanation.
(5) As the MRO, if you determine that there is a legitimate medical explanation, you must cancel the test and inform ODAPC in writing of the determination and the basis for it (e.g., referral physician’s findings, evidence produced by the employee).
(6) As the MRO, if you determine that there is not a legitimate medical explanation, you must report the test to the DER as a verified refusal to test because of adulteration or substitution.
(h) The following are examples of types of evidence an employee could present to support an assertion of a legitimate medical explanation for a substituted result:
(1) Medically valid evidence demonstrating that the employee is capable of physiologically producing urine meeting the creatinine and specific gravity criteria of §40.209(b).
(i) To be regarded as medically valid, the evidence must have been gathered using appropriate methodology and controls to ensure its accuracy and reliability.
(ii) Assertion by the employee that his or her personal characteristics (e.g., with respect to race, gender, weight, diet, working conditions) are responsible for the substituted result does not, in itself, constitute a legitimate medical explanation. To make a case that there is a legitimate medical explanation, the employee must present evidence showing that the cited personal characteristics actually result in the physiological production of urine meeting the creatinine and specific gravity criteria of §40.209 (b).
(2) Information from a medical evaluation under paragraph (g) of this section that the individual has a medical condition that has been demonstrated to cause the employee to physiologically produce urine meeting the creatinine and specific gravity criteria of §40.209 (b).
(i) A finding or diagnosis by the physician that an employee has a medical condition, in itself, does not constitute a legitimate medical explanation.
(ii) To establish there is a legitimate medical explanation, the employee must demonstrate that the cited medical condition actually results in the physiological production of urine meeting the creatinine and specific gravity criteria of §40.209 (b).

§40.217 What does the second laboratory do with the split specimen when it is tested to reconfirm an adulterated test result?
As the laboratory testing the split specimen, you must test the split specimen for the adulterant detected in the primary specimen using the same criteria that were used for the primary specimen or HHS guidance, as applicable. The result of the primary specimen is reconfirmed if the split specimen meets these criteria.

§40.219 What does the second laboratory do with the split specimen when it is tested to reconfirm a substituted test result?
As the laboratory testing the split specimen, you must test the split specimen using the criteria of §40.209 (b), just as you would do for a primary specimen. The result of the primary specimen is reconfirmed if the split specimen meets these criteria.

§40.221 What information do laboratories report to MROs regarding split specimen results?
(a) As the laboratory responsible for testing the split specimen, and you are using the Federal Drug Testing Custody and Control Form (CCF) issued by HHS on June 23, 2000, you must report split specimen test results in adulteration and substitution situations by checking the “Reconfirmed” box or the “Failed to Reconfirm” box (Step 5(b)) on Copy 1 of the CCF.
(b) If you check the “Failed to Reconfirm” box, one of the following statements must be included (as appropriate) on the “Reason” line (Step 5(b)):
(1) Drug(s)/metabolite(s) not detected.”
(2) “Adulterant not found within criteria.”
(3) “Specimen not consistent with substitution criteria [specify creatinine, specific gravity, or both]”
(4) “Specimen not available for testing.”
(c ) If you are using the CCF issued by HHS prior to June 23, 2000, enter the information referenced in paragraph (b) (2), (3), or (4) of this section on the “remarks” line.
(d) As the laboratory certifying scientist, enter your name, sign, and date the CCF.

§40.223 What does the MRO do with split specimen laboratory results?
As an MRO, you must take the following actions when a laboratory reports the following results of split specimen tests concerning adulterated or substituted specimens:
(a) Reconfirmed. (1) In the case of a reconfirmed positive test for a drug or drug metabolite, report the reconfirmation to the DER and the employee.
(2) In the case of a reconfirmed adulterated or substituted result, report to the DER and the employee that the specimen was adulterated or substituted, either of which constitutes a refusal to test. Therefore, “refusal to test” is the final result.
(b) Failed to Reconfirm: Drug(s)/Drug Metabolite(s) Not Detected. (1) Report to the DER and the employee that both tests must be cancelled.
(2) Inform ODAPC of the failure to reconfirm.
(c) Failed to Reconfirm: Adulterated or Substituted (as appropriate); Criteria Not Met. (1) Report to the DER and the employee that both tests must be cancelled.
(2) Inform ODAPC of the failure to reconfirm.
(d) Failed to Reconfirm: Specimen not Available for Testing. (1) Report to the DER and the employee that both tests must be cancelled and the reason for cancellation.
(2) Direct the DER to ensure the immediate collection of another specimen from the employee under direct observation, with no notice given to the employee of this collection requirement until immediately before the collection.
(3) Inform ODAPC of the failure to reconfirm.
(e) Enter your name, sign and date the appropriate copy of the CCF.
(f) Send a legible copy of the appropriate copy of the CCF (or a signed and dated letter) to the employer and keep a copy for your records.

§40.225 What is a refusal to take a DOT drug test, and what are the consequences?
(a) [Reserved]
(b) As an employee, if the MRO reports that you have a verified adulterated or substituted test result, you have refused to take a drug test.
(c) As an employee, if you refuse to take a drug test, you incur the consequences specified under DOT agency regulations for a violation of those DOT agency regulations.
(d) [Reserved]
(e) [Reserved]

Subpart F – Public Interest Exclusions
§§40.301 – 40.359 [Reserved]
§40.361 What is the purpose of a public interest exclusion (PIE)?
(a) To protect the public interest, including protecting transportation employers and employees from serious noncompliance with DOT drug and alcohol testing rules, the Department’s policy is to ensure that employers conduct business only with responsible service agents.
(b) The Department therefore uses PIEs to exclude from participation in DOT’s drug and alcohol testing program any service agent who, by serious noncompliance with this part or other DOT agency drug and alcohol testing regulations, has shown that it is not currently acting in a responsible manner.
(c) A PIE is a serious action that the Department takes only to protect the public interest. We intend to use PIEs only to remedy situations of serious noncompliance. PIEs are not used for the purpose of punishment.
(d) Nothing in this subpart precludes a DOT agency or the Inspector General from taking other action authorized by its regulations with respect to service agents or employers that violate its regulations.

§40.363 On what basis may the Department issue a PIE?
(a) If you are a service agent, the Department may issue a PIE concerning you if we determine that you have failed or refused to provide drug or alcohol testing services consistent with the requirements of this part or a DOT agency drug and alcohol regulation.
(b) The Department also may issue a PIE if you have failed to cooperate with DOT agency representatives concerning inspections, complaint investigations, compliance and enforcement reviews, or requests for documents and other information about compliance with this part or DOT agency drug and alcohol regulations.

§40.365 What is the Department’s policy concerning starting a PIE proceeding?
(a) It is the Department’s policy to start a PIE proceeding only in cases of serious, uncorrected noncompliance with the provisions of this part, affecting such matters as safety, the outcomes of test results, privacy and confidentiality, due process and fairness for employees, the honesty and integrity of the testing program, and cooperation with or provision of information to DOT agency representatives.
(b) The following are examples of the kinds of serious noncompliance that, as a matter of policy, the Department views as appropriate grounds for starting a PIE proceeding. These examples are not intended to be an exhaustive or exclusive list of the grounds for starting a PIE proceeding. We intend them to illustrate the level of seriousness that the Department believes supports starting a PIE proceeding. The examples follow:
(1) For an MRO, verifying tests positive without interviewing the employees as required by this part or providing MRO services without meeting the qualifications for an MRO required by this part;
(2) For a laboratory, refusing to provide information to the Department, an employer, or an employee as required by this part; or a pattern or practice of testing errors that result in the cancellation of tests. (As a general matter of policy, the Department does not intend to initiate a PIE proceeding concerning a laboratory with respect to matters on which HHS initiates certification actions under its laboratory guidelines.);
(3) For a collector, a pattern or practice of directly observing collections when doing so is unauthorized, or failing or refusing to directly observe collections when doing so is mandatory;
(4) For collectors, BATs, or STTs, a pattern or practice of using forms, testing equipment, or collection kits that do not meet the standards in this part;
(5) For a collector, BAT, or STT, a pattern or practice of “fatal flaws” or other significant uncorrected errors in the collection process;
(6) For a laboratory, MRO or C/TPA, failing or refusing to report tests results as required by this part or DOT agency regulations;
(7) For a laboratory, falsifying, concealing, or destroying documentation concerning any part of the drug testing process, including, but not limited to, documents in a “litigation package”;
(8) For SAPs, providing SAP services while not meeting SAP qualifications required by this part or performing evaluations without face-to-face interviews;
(9) For any service agent, maintaining a relationship with another party that constitutes a conflict of interest under this part (e.g., a laboratory that derives a financial benefit from having an employer use a specific MRO);
(10) For any service agent, representing falsely that the service agent or its activities is approved or certified by the Department or a DOT agency;
(11) For any service agent, disclosing an employee’s test result information to any party this part or a DOT agency regulation does not authorize, including by obtaining a “blanket” consent from employees or by creating a data base from which employers or others can retrieve an employee’s DOT test results without the specific consent of the employee;
(12) For any service agent, interfering or attempting to interfere with the ability of an MRO to communicate with the Department, or retaliating against an MRO for communicating with the Department;
(13) For any service agent, directing or recommending that an employer fail or refuse to implement any provision of this part; or
(14) With respect to noncompliance with a DOT agency regulation, conduct that affects important provisions of Department-wide concern (e.g., failure to properly conduct the selection process for random testing).

§40.367 Who initiates a PIE proceeding?
The following DOT officials may initiate a PIE proceeding:
(a) The drug and alcohol program manager of a DOT agency;
(b) An official of ODAPC, other than the Director; or
(c) The designee of any of these officials.

§ 40.369 What is the discretion of an initiating official in starting a PIE proceeding?
(a) Initiating officials have broad discretion in deciding whether to start a PIE proceeding.
(b) In exercising this discretion, the initiating official must consider the Department’s policy regarding the seriousness of the service agent’s conduct (see §40.365) and all information he or she has obtained to this point concerning the facts of the case. The initiating official may also consider the availability of the resources needed to pursue a PIE proceeding.
(c) A decision not to initiate a PIE proceeding does not necessarily mean that the Department regards a service agent as being in compliance or that the Department may not use other applicable remedies in a situation of noncompliance.

§40.371 On what information does an initiating official rely in deciding whether to start a PIE proceeding?
(a) An initiating official may rely on credible information from any source as the basis for starting a PIE proceeding.
(b) Before sending a correction notice (see §40.373), the initiating official informally contacts the service agent to determine if there is any information that may affect the initiating official’s determination about whether it is necessary to send a correction notice. The initiating official may take any information resulting from this contact into account in determining whether to proceed under this subpart.

§40.373 Before starting a PIE proceeding, does the initiating official give the service agent an opportunity to correct problems?
(a) If you are a service agent, the initiating official must send you a correction notice before starting a PIE proceeding.
(b) The correction notice identifies the specific areas in which you must come into compliance in order to avoid being subject to a PIE proceeding.
(c) If you make and document changes needed to come into compliance in the areas listed in the correction notice to the satisfaction of the initiating official within 60 days of the date you receive the notice, the initiating official does not start a PIE proceeding. The initiating official may conduct appropriate fact finding to verify that you have made and maintained satisfactory corrections. When he or she is satisfied that you are in compliance, the initiating official sends you a notice that the matter is concluded.

§40.375 How does the initiating official start a PIE proceeding?
(a) As a service agent, if your compliance matter is not correctable (see §40.373(a)), or if have not resolved compliance matters as provided in §40.373(c), the initiating official starts a PIE proceeding by sending you a notice of proposed exclusion (NOPE). The NOPE contains the initiating official’s recommendations concerning the issuance of a PIE, but it is not a decision by the Department to issue a PIE.
(b) The NOPE includes the following information:
(1) A statement that the initiating official is recommending that the Department issue a PIE concerning you;
(2) The factual basis for the initiating official’s belief that you are not providing drug and/or alcohol testing services to DOT-regulated employers consistent with the requirements of this part or are in serious noncompliance with a DOT agency drug and alcohol regulation;
(3) The factual basis for the initiating official’s belief that your noncompliance has not been or cannot be corrected;
(4) The initiating official’s recommendation for the scope of the PIE;
(5) The initiating official’s recommendation for the duration of the PIE; and
(6) A statement that you may contest the issuance of the proposed PIE, as provided in §40.379.
(c) The initiating official sends a copy of the NOPE to the ODAPC Director at the same time he or she sends the NOPE to you.

§40.377 Who decides whether to issue a PIE?
(a) The ODAPC Director, or his or her designee, decides whether to issue a PIE. If a designee is acting as the decisionmaker, all references in this subpart to the Director refer to the designee.
(b) To ensure his or her impartiality, the Director plays no role in the initiating official’s determination about whether to start a PIE proceeding.
(c) There is a “firewall” between the initiating official and the Director. This means that the initiating official and the Director are prohibited from having any discussion, contact, or exchange of information with one another about the matter, except for documents and discussions that are part of the record of the proceeding.

§40.379 How do you contest the issuance of a PIE?
(a) If you receive a NOPE, you may contest the issuance of the PIE.
(b) If you want to contest the proposed PIE, you must provide the Director information and argument in opposition to the proposed PIE in writing, in person, and/or through a representative. To contest the proposed PIE, you must take one or more of the steps listed in this paragraph (b) within 30 days after you receive the NOPE.
(1) You may request that the Director dismiss the proposed PIE without further proceedings, on the basis that it does not concern serious noncompliance with this part or DOT agency regulations, consistent with the Department’s policy as stated in §40.365.
(2) You may present written information and arguments, consistent with the provisions of §40.381, contesting the proposed PIE.
(3) You may arrange with the Director for an informal meeting to present your information and arguments.
(c) If you do not take any of the actions listed in paragraph (b) of this section within 30 days after you receive the NOPE, the matter proceeds as an uncontested case. In this event, the Director makes his or her decision based on the record provided by the initiating official (i.e., the NOPE and any supporting information or testimony) and any additional information the Director obtains.

§40.381 What information do you present to contest the proposed issuance of a PIE?
(a) As a service agent who wants to contest a proposed PIE, you must present at least the following information to the Director:
(1) Specific facts that contradict the statements contained in the NOPE (see §40.375(b)(2) and (3)). A general denial is insufficient to raise a genuine dispute over facts material to the issuance of a PIE;
(2) Identification of any existing, proposed or prior PIE; and
(3) Identification of your affiliates, if any.
(b) You may provide any information and arguments you wish concerning the proposed issuance, scope and duration of the PIE (see §40.375 (b) (4) and (5).
(c) You may provide any additional relevant information or arguments concerning any of the issues in the matter.

§40.383 What procedures apply if you contest the issuance of a PIE?
(a) DOT conducts PIE proceedings in a fair and informal manner. The Director may use flexible procedures to allow you to present matters in opposition. The Director is not required to follow formal rules of evidence or procedure in creating the record of the proceeding.
(b) The Director will consider any information or argument he or she determines to be relevant to the decision on the matter.
(c) You may submit any documentary evidence you want the Director to consider. In addition, if you have arranged an informal meeting with the Director, you may present witnesses and confront any person the initiating official presents as a witness against you.
(d) In cases where there are material factual issues in dispute, the Director or his or her designee may conduct additional fact-finding.
(e) If you have arranged a meeting with the Director, the Director will make a transcribed record of the meeting available to you on your request. You must pay the cost of transcribing and copying the meeting record.

§40.385 Who bears the burden of proof in a PIE proceeding?
(a) As the proponent of issuing a PIE, the initiating official bears the burden of proof.
(b) This burden is to demonstrate, by a preponderance of the evidence, that the service agent was in serious noncompliance with the requirements of this part for drug and/or alcohol testing-related services or with the requirements of another DOT agency drug and alcohol testing regulation.

§40.387 What matters does the Director decide concerning a proposed PIE?
(a) Following the service agent’s response (see §40.379(b)) or, if no response is received, after 30 days have passed from the date on which the service agent received the NOPE, the Director may take one of the following steps:
(1) In response to a request from the service agent (see §40.379(b)(1)) or on his or her own motion, the Director may dismiss a PIE proceeding if he or she determines that it does not concern serious noncompliance with this part or DOT agency regulations, consistent with the Department’s policy as stated in §40.365.
(i) If the Director dismisses a proposed PIE under this paragraph (a), the action is closed with respect to the noncompliance alleged in the NOPE.
(ii) The Department may initiate a new PIE proceeding against you on the basis of different or subsequent conduct that is in noncompliance with this part or other DOT drug and alcohol testing rules.
(2) If the Director determines that the initiating official’s submission does not have complete information needed for a decision, the Director may remand the matter to the initiating official. The initiating official may resubmit the matter to the Director when the needed information is complete. If the basis for the proposed PIE has changed, the initiating official must send an amended NOPE to the service agent.
(b) The Director makes determinations concerning the following matters in any PIE proceeding that he or she decides on the merits:
(1) Any material facts that are in dispute;
(2) Whether the facts support issuing a PIE;
(3) The scope of any PIE that is issued; and
(4) The duration of any PIE that is issued.

§40.389 What factors may the Director consider?
This section lists examples of the kind of mitigating and aggravating factors that the Director may consider in determining whether to issue a PIE concerning you, as well as the scope and duration of a PIE. This list is not exhaustive or exclusive. The Director may consider other factors if appropriate in the circumstances of a particular case. The list of examples follows:
(a) The actual or potential harm that results or may result from your noncompliance;
(b) The frequency of incidents and/or duration of the noncompliance;
(c) Whether there is a pattern or prior history of noncompliance;
(d) Whether the noncompliance was pervasive within your organization, including such factors as the following:
(1) Whether and to what extent your organization planned, initiated, or carried out the noncompliance;
(2) The positions held by individuals involved in the noncompliance, and whether your principals tolerated their noncompliance; and
(3) Whether you had effective standards of conduct and control systems (both with respect to your own organization and any contractors or affiliates) at the time the noncompliance occurred;
(e) Whether you have demonstrated an appropriate compliance disposition, including such factors as the following:
(1) Whether you have accepted responsibility for the noncompliance and recognize the seriousness of the conduct that led to the cause for issuance of the PIE;
(2) Whether you have cooperated fully with the Department during the investigation. The Director may consider when the cooperation began and whether you disclosed all pertinent information known to you;
(3) Whether you have fully investigated the circumstances of the noncompliance forming the basis for the PIE and, if so, have made the result of the investigation available to the Director;
(4) Whether you have taken appropriate disciplinary action against the individuals responsible for the activity that constitutes the grounds for issuance of the PIE; and
(5) Whether your organization has taken appropriate corrective actions or remedial measures, including implementing actions to prevent recurrence;
(f) With respect to noncompliance with a DOT agency regulation, the degree to which the noncompliance affects matters common to the DOT drug and alcohol testing program;
(g) Other factors appropriate to the circumstances of the case.

§40.391 What is the scope of a PIE?
(a) The scope of a PIE is the Department’s determination about the divisions, organizational elements, types of services, affiliates, and/or individuals (including direct employees of a service agent and its contractors) to which a PIE applies.
(b) If, as a service agent, the Department issues a PIE concerning you, the PIE applies to all your divisions, organizational elements, and types of services that are involved with or affected by the noncompliance that forms the factual basis for issuing the PIE.
(c) In the NOPE (see §40.375(b)(4)), the initiating official sets forth his or her recommendation for the scope of the PIE. The proposed scope of the PIE is one of the elements of the proceeding that the service agent may contest (see §40.381(b)) and about which the Director makes a decision (see §40.387(b)(3)).
(d) In recommending and deciding the scope of the PIE, the initiating official and Director, respectively, must take into account the provisions of paragraphs (e) through (j) of this section.
(e) The pervasiveness of the noncompliance within a service agent’s organization (see §40.389(d)) is an important consideration in determining the scope of a PIE. The appropriate scope of a PIE grows broader as the pervasiveness of the noncompliance increases.
(f) The application of a PIE is not limited to the specific location or employer at which the conduct that forms the factual basis for issuing the PIE was discovered.
(g) A PIE applies to your affiliates, if the affiliate is involved with or affected by the conduct that forms the factual basis for issuing the PIE.
(h) A PIE applies to individuals who are officers, employees, directors, shareholders, partners, or other individuals associated with your organization in the following circumstances:
(1) Conduct forming any part of the factual basis of the PIE occurred in connection with the individual’s performance of duties by or on behalf of your organization; or
(2) The individual knew of, had reason to know of, approved, or acquiesced in such conduct. The individual’s acceptance of benefits derived from such conduct is evidence of such knowledge, acquiescence, or approval.
(i) If a contractor to your organization is solely responsible for the conduct that forms the factual basis for a PIE, the PIE does not apply to the service agent itself unless the service agent knew or should have known about the conduct and did not take action to correct it.
(j) PIEs do not apply to drug and alcohol testing that DOT does not regulate.
(k) The following examples illustrate how the Department intends the provisions of this section to work:
Example 1 to §40.391. Service Agent P provides a variety of drug testing services. P’s SAP services are involved in a serious violation of this Part 40. However, P’s other services fully comply with this part, and P’s overall management did not plan or concur in the noncompliance, which in fact was contrary to P’s articulated standards. Because the noncompliance was isolated in one area of the organization’s activities, and did not pervade the entire organization, the scope of the PIE could be limited to SAP services.
Example 2 to §40.391. Service Agent Q provides a similar variety of services. The conduct forming the factual basis for a PIE concerns collections for a transit authority. As in Example 1, the noncompliance is not pervasive throughout Q’s organization. The PIE would apply to collections at all locations served by Q, not just the particular transit authority or not just in the state in which the transit authority is located.
Example 3 to §40.391. Service Agent R provides a similar array of services. One or more of the following problems exists: R’s activities in several areas – collections, MROs, SAPs, protecting the confidentiality of information – are involved in serious noncompliance; DOT determines that R’s management knew or should have known about serious noncompliance in one or more areas, but management did not take timely corrective action; or, in response to an inquiry from DOT personnel, R’s management refuses to provide information about its operations. In each of these three cases, the scope of the PIE would include all aspects of R’s services.
Example 4 to §40.391. Service Agent W provides only one kind of service (e.g., laboratory or MRO services). The Department issues a PIE concerning these services. Because W only provides this one kind of service, the PIE necessarily applies to all its operations.
Example 5 to §40.391. Service Agent X, by exercising reasonably prudent oversight of its collection contractor, should have known that the contractor was making numerous “fatal flaws” in tests. Alternatively, X received a correction notice pointing out these problems in its contractor’s collections. In neither case did X take action to correct the problem. X, as well as the contractor, would be subject to a PIE with respect to collections.
Example 6 to §40.391. Service Agent Y could not reasonably have known that one of its MROs was regularly failing to interview employees before verifying tests positive. When it received a correction notice, Y immediately dismissed the erring MRO. In this case, the MRO would be subject to a PIE but Y would not.
Example 7 to §40.391. The Department issues a PIE with respect to Service Agent Z. Z provides services for DOT-regulated transportation employers, a Federal agency under the HHS-regulated Federal employee testing program, and various private businesses and public agencies that DOT does not regulate. The PIE applies only to the DOT-regulated transportation employers with respect to their DOT-mandated testing, not to the Federal agency or the other public agencies and private businesses. The PIE does not prevent the non-DOT regulated entities from continuing to use Z’s services.

§40.393 How long does a PIE stay in effect?
(a) In the NOPE (see §40.375(b)(5)), the initiating official proposes the duration of the PIE. The duration of the PIE is one of the elements of the proceeding that the service agent may contest (see §40.381(b)) and about which the Director makes a decision (see §40.387(b)(4)).
(b) In deciding upon the duration of the PIE, the Director considers the seriousness of the conduct on which the PIE is based and the continued need to protect employers and employees from the service agent’s noncompliance. The Director considers factors such as those listed in §40.389 in making this decision.
(c) The duration of a PIE will be between one and five years, unless the Director reduces its duration under §40.407.

§40.395 Can you settle a PIE proceeding?
At any time before the Director’s decision, you and the initiating official can, with the Director’s concurrence, settle a PIE proceeding.

§40.397 When does the Director make a PIE decision?
The Director makes his or her decision within 60 days of the date when the record of a PIE proceeding is complete (including any meeting with the Director and any additional fact-finding that is necessary). The Director may extend this period for good cause for additional periods of up to 30 days.

§40.399 How does the Department notify service agents of its decision?
If you are a service agent involved in a PIE proceeding, the Director provides you written notice as soon as he or she makes a PIE decision. The notice includes the following elements:
(a) If the decision is not to issue a PIE, a statement of the reasons for the decision, including findings of fact with respect to any material factual issues that were in dispute.
(b) If the decision is to issue a PIE —
(1) A reference to the NOPE;
(2) A statement of the reasons for the decision, including findings of fact with respect to any material factual issues that were in dispute;
(3) A statement of the scope of the PIE; and
(4) A statement of the duration of the PIE.

§40.401 How does the Department notify employers and the public about a PIE?
(a) The Department maintains a document called the “List of Excluded Drug and Alcohol Service Agents.” This document may be found on the Department’s web site (http://www.dot.gov/ost/dapc). You may also request a copy of the document from ODAPC.
(b) When the Director issues a PIE, he or she adds to the List the name and address of the service agent, and any other persons or organizations, to whom the PIE applies and information about the scope and duration of the PIE.
(c) When a service agent ceases to be subject to a PIE, the Director removes this information from the List.
(d) The Department also publishes a Federal Register notice to inform the public on any occasion on which a service agent is added to or taken off the List.

§40.403 Must a service agent notify its clients when the Department issues a PIE?
(a) As a service agent, if the Department issues a PIE concerning you, you must notify each of your DOT-regulated employer clients, in writing, about the issuance, scope, duration, and effect of the PIE. You may meet this requirement by sending a copy of the Director’s PIE decision or by a separate notice. You must send this notice to each client within three working days of receiving from the Department the notice provided for in §40.399(b).
(b) As part of the notice you send under paragraph (a) of this section, you must offer to transfer immediately all records pertaining to the employer and its employees to the employer or to any other service agent the employer designates. You must carry out this transfer as soon as the employer requests it.

§40.405 May the Federal courts review PIE decisions?
The Director’s decision is a final administrative action of the Department. Like all final administrative actions of Federal agencies, the Director’s decision is subject to judicial review under the Administrative Procedure Act (5 U.S.C. 551 et seq.).

§40.407 May a service agent ask to have a PIE reduced or terminated?
(a) Yes, as a service agent concerning whom the Department has issued a PIE, you may request that the Director terminate a PIE or reduce its duration and/or scope. This process is limited to the issues of duration and scope. It is not an appeal or reconsideration of the decision to issue the PIE.
(b) Your request must be in writing and supported with documentation.
(c) You must wait at least nine months from the date on which the Director issued the PIE to make this request.
(d) The initiating official who was the proponent of the PIE may provide information and arguments concerning your request to the Director.
(e) If the Director verifies that the sources of your noncompliance have been eliminated and that all drug or alcohol testing-related services you would provide to DOT-regulated employers will be consistent with the requirements of this part, the Director may issue a notice terminating or reducing the PIE.

§40.409 What does the issuance of a PIE mean to transportation employers?
(a) As an employer, you are deemed to have notice of the issuance of a PIE when it appears on the List mentioned in §40.401(a) or the notice of the PIE appears in the Federal Register as provided in §40.401(d). You should check this List to ensure that any service agents you are using or planning to use are not subject to a PIE.
(b) As an employer who is using a service agent concerning whom a PIE is issued, you must stop using the services of the service agent no later than 90 days after the Department has published the decision in the Federal Register or posted it on its web site. You may apply to the ODAPC Director for an extension of 30 days if you demonstrate that you cannot find a substitute service agent within 90 days.
(c) Except during the period provided in paragraph (b) of this section, you must not, as an employer, use the services of a service agent that are covered by a PIE that the Director has issued under this subpart. If you do so, you are in violation of the Department’s regulations and subject to applicable DOT agency sanctions (e.g., civil penalties, withholding of Federal financial assistance).
(d) You also must not obtain drug or alcohol testing services through a contractor or affiliate of the service agent to whom the PIE applies.
Example to Paragraph (d). Service Agent R was subject to a PIE with respect to SAP services. As an employer, not only must you not use R’s own SAP services, but you also must not use SAP services you arrange through R, such as services provided by a subcontractor or affiliate of R or a person or organization that receives financial gain from its relationship with R.
(e) This section’s prohibition on using the services of a service agent concerning which the Director has issued a PIE applies to employers in all industries subject to DOT drug and alcohol testing regulations.
Example to Paragraph (e). The initiating official for a PIE was the FAA drug and alcohol program manager, and the conduct forming the basis of the PIE pertained to the aviation industry. As a motor carrier, transit authority, pipeline, railroad, or maritime employer, you are also prohibited from using the services of the service agent involved in connection with the DOT drug and alcohol testing program.
(f) The issuance of a PIE does not result in the cancellation of drug or alcohol tests conducted using the service agent involved before the issuance of the Director’s decision or up to 90 days following its publication in the Federal Register or posting on the Department’s web site, unless otherwise specified in the Director’s PIE decision or the Director grants an extension as provided in paragraph (b) of this section.
Example to Paragraph (f). The Department issues a PIE concerning Service Agent N on September 1. All tests conducted using N’s services before September 1, and through November 30, are valid for all purposes under DOT drug and alcohol testing regulations, assuming they meet all other regulatory requirements.

§40.411 What is the role of the DOT Inspector General’s office?
(a) Any person may bring concerns about waste, fraud, or abuse on the part of a service agent to the attention of the DOT Office of Inspector General.
(b) In appropriate cases, the Office of Inspector General may pursue criminal or civil remedies against a service agent.
(c) The Office of Inspector General may provide factual information to other DOT officials for use in a PIE proceeding.

§40.413 How are notices sent to service agents?
(a) If you are a service agent, DOT sends notices to you, including correction notices, notices of proposed exclusion, decision notices, and other notices, in any of the ways mentioned in paragraph (b) or (c) of this section.
(b) DOT may send a notice to you, your identified counsel, your agent for service of process, or any of your partners, officers, directors, owners, or joint venturers to the last known street address, fax number, or e-mail address. DOT deems the notice to have been received by you if sent to any of these persons.
(c) DOT considers notices to be received by you –
(1) When delivered, if DOT mails the notice to the last known street address, or five days after we send it if the letter is undeliverable;
(2) When sent, if DOT sends the notice by fax or five days after we send it if the fax is undeliverable; or
(3) When delivered, if DOT sends the notice by e-mail or five days after DOT sends it if the e-mail is undeliverable.

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