Final Rule; Technical Amendment.
On September 27, 2010, the U.S. Department of Transportation (DOT) published an interim final rule (IFR) authorizing the use of a new Federal Drug Testing Custody and Control Form (CCF) in its drug testing program. Use of the form is authorized beginning October 1, 2010. This final rule responds to comments to the IFR and will finalize the authorization and procedures for using the new CCF for DOT-required drug tests. The intended effect of this final rule is to finalize the authority for use of the new CCF and to make a technical amendment to its drug testing procedures by amending a provision of the rule which was inadvertently omitted from a final rule in August 2010. The September 27, 2010 final rule was published under RIN 2105-AE03, however, it was inadvertently shown as a completed action on the Fall 2010 Agenda; this action replaces RIN 2105-AE03.
The rule is effective September 27, 2011.
FOR FURTHER INFORMATION CONTACT:
Bohdan Baczara, U.S. Department of Transportation, Office of Drug and Alcohol Policy and Compliance, 1200 New Jersey Avenue, SE., Washington, DC 20590; 202-366-3784 (voice), 202-366-3897 (fax), or firstname.lastname@example.org (e-mail).
Background and Purpose
All urine specimens collected under the DOT drug testing regulation, 49 CFR Part 40, must be collected using chain-of-custody procedures that incorporate the use of the CCF promulgated by the Department of Health and Human Services (HHS). On November 17, 2009, HHS published a proposal to revise the CCF [74 FR 59196]. In their proposal, HHS stated that the CCF is used for the Federal workplace drug testing program, but also pointed out that DOT “* * *requires its regulated industries to use the Federal CCF” [74 FR 59196]. Because many of the commentors to the HHS proposal were transportation industry employers, Consortia/Third-party Administrators (C/TPAs), and associations, the Department was confident the commentors understood the new CCF would be used in the DOT-regulated program. All the comments submitted were thoroughly reviewed by HHS and taken into consideration in fashioning the new CCF. The Department worked closely with HHS on the new CCF. HHS announced the new CCF in the Federal Register [75 FR 41488]. The CCF became effective date of October 1, 2010.
However, because of the short time frame between the HHS publication of the new CCF and its October 1, 2010 effective date, the Department did not have an opportunity to propose a rulemaking and therefore issued an Interim Final Rule (IFR) on September 27, 2010 [75 FR 59105] authorizing DOT-regulated employers to also begin using the new CCF on October 1, 2010. The Department sought comments only on the actual implementation of the new CCF, and not on the form itself because HHS already sought and received comments on the form and its use because many of the commentors to the HHS proposal were transportation industry employers, C/TPAs, and associations. In the IFR, the Department made minor procedural amendments to the regulation to merely reflect the changes HHS made to the revised CCF, and clarified how collectors, laboratories, and medical review officers (MROs) must use the new form in the DOT regulated context. There were 15 comments from four commentors.
The Department is also making a technical amendment to address an omission in the rule text of a final rule published on August 16, 2010 [75 FR 49850]. Specifically, we had removed the requirement in § 40.121(d) for the MRO to complete continuing education units to satisfy the requalification training requirement but we failed to amend the definition of “Continuing education” in § 40.3 to reflect this change. We do so in this Final Rule.
The following part of the preamble discusses comments to each of the amended rule text sections.
Section 40.14What collection information must employers provide to collectors?
The Department added a new § 40.14 to put into one section the information employers or their C/TPAs have been routinely providing collectors or should have been providing collectors; information such as, the reason for the test, whether the test is to be conducted under direct observation, the MRO name and address, and employee information ( e.g., name and SSN or ID number), etc. All of this information would need to be provided in Step 1 of the CCF. Since a new Step 1-D was added to the CCF to specify which DOT Agency regulates the employee's safety-sensitive function, we included this among the information the employer or its C/TPA must provide to the collector.
One commentor, a large laboratory with many collection sites, concurred with the requirement for employers or C/TPAs to ensure the collector has the necessary information to complete Step 1. The commentor went on to say that it relied on the employer or C/TPA to pre-mark the demographic information ( e.g., test reason, testing authority) in Step 1 since its collection sites don't keep employer-specific CCFs at their sites and the employee may not know this information. When the employer pre-marks this information, this helps ensure the information is completed correctly. The Department agrees. In the event Step 1 is not pre-marked, the employer would need to ensure the information is provided to the collector.
Two commentors, apparently from the same collection site, were concerned that requiring the employer to provide the DOT Agency information would be confusing for the employers and that not knowing this information would delay the testing process. They stated “* * * there are many instances when the employer has no idea if their donor is DOT or non-DOT” and “When inquiring of employers' DER to supply this information the majority of the responses are 'I don't know!' The Department also received several telephonic requests for clarification since October 1 in which collectors questioned how they would know this information if the employer didn't know it themselves.
The Department believes the collector should never be put in a situation to determine the DOT Agency that regulates an employee's safety-sensitive functions. This is the employer's responsibility. Furthermore, the Department was surprised to hear that any employer currently regulated by DOT would not know which DOT Agency regulates it. We can only surmise this is a rare occurrence and there is no reason to believe it is a systemic problem. Perhaps it was because the employer forgot the specific abbreviation of its respective regulator: Federal Motor Carrier Safety Administration (FMCSA); Federal Aviation Administration (FAA); Federal Railroad Administration (FRA); Federal Transit Administration (FTA); Pipeline and Hazardous Materials Safety Administration (PHMSA); and the United States Coast Guard (USCG). 1
Nevertheless, not knowing this fundamental concept raised serious concerns and compliance questions. For example: Is the employer subject to the DOT's drug and alcohol testing regulations? If the employer is covered by the DOT regulations, then other questions arise. Is the employer testing its employees at the proper random testing rates? Is the employer conducting post-accident tests when required? Is the employer providing the correct educational material to its employees as required by the DOT regulations? Is the employer appropriately filling-out and submitting Management Information System (MIS) reports?
In response to the comment that employers do not know which DOT Agency regulates them or their employees' safety-sensitive functions, we encourage employers and their C/TPAs to review the guidance documents available to them on our site http://www.dot.gov/odapc and affirm their regulating DOT Agency. The Department is also providing the following to assist employers and C/TPAs with understanding these critical elements:
Federal Motor Carrier Safety Administration (FMCSA)
Covered employee: A person who operates (i.e., drives) a Commercial Motor Vehicle (CMV) with a gross vehicle weight rating (gvwr) of 26,001 or more pounds; or is designed to transport 16 or more occupants (to include the driver); or is of any size and is used in the transport of hazardous materials that require the vehicle to be placarded.
Federal Railroad Administration (FRA)
Covered employee: A person who performs hours of service functions at a rate sufficient to be placed into the railroad's random testing program. Categories of personnel who normally perform these functions are locomotive engineers, trainmen, conductors, switchmen, locomotive hostlers/helpers, utility employees, signalmen, operators, and train dispatchers.
Federal Aviation Administration (FAA)
Covered employee: A person who performs flight crewmember duties, flight attendant duties, flight instruction duties, aircraft dispatch duties, aircraft maintenance or preventive maintenance duties; ground security coordinator duties; aviation screening duties; and air traffic control duties.
Note: Anyone who performs the above duties directly or by contract for a part 119 certificate holder authorized to operate under parts 121 and/or 135, air tour operators defined in 14 CFR part 91.147, and air traffic control facilities not operated by the Government are considered covered employees.
Federal Transit Administration (FTA)
Covered employee: A person who performs a revenue vehicle operation; revenue vehicle and equipment maintenance; revenue vehicle control or dispatch (optional); Commercial Drivers License non-revenue vehicle operation; or armed security duties.
Pipeline and Hazardous Materials Safety Administration (PHMSA)
Covered employee: A person who performs on a pipeline or liquefied natural gas (LNG) facility an operation, maintenance, or emergency-response function.
United States Coast Guard (USCG)
Covered employee: A person who is on board a vessel acting under the authority of a license, certificate of registry, or merchant mariner's document. Also, a person engaged or employed on board a U.S. owned vessel and such vessel is required to engage, employ or be operated by a person holding a license, certificate of registry, or merchant mariner's document.
Employers and their C/TPAs that may have DOT Agency-specific questions can find the DOT Agency drug and alcohol program manager contact information at http://www.dot.gov/odapc/oamanagers.html.
Section 40.23What actions do employers take after receiving verified test results?
In paragraph (f)(4) of this section, we added the DOT Agency to the items an employer must instruct the collector to note on the CCF. There were no comments to this section.
Section 40.45What form is used to document a DOT urine collection?
In paragraph (b) of this section, we changed the date after which an expired CCF is not to be used and in paragraph (c)(3) of this section, we permitted employers to preprint the box of the DOT Agency under whose authority the test will occur. There were two comments to this section. One commentor thanked the Department for authorizing the use of the old CCF until September 30, 2011, stating the year-long transition to the new CCF would provide employers and their service agents ample time to deplete their stock of old CCFs. The other commentor pointed out that the old CCF expires November 30, 2011, and suggested that the inadvertent use of the old CCF be permitted until this date. The Department agrees with the commentor about extending the use of the old CCF until November 30, 2011 so that it coincides with the form's actual expiration date. We have amended the rule text to reflect this change, so that the use of an old CCF would be a flaw that would require correction after November 30, 2011.
Section 40.63What steps does the collector take in the collection process before the employee provides a urine specimen?
In paragraph (e) of this section we revised the rule text to provide the collector with specific instructions on completing Step 2 of the CCF. One commentor concurred with this change. The same commentor asked for clarification that a collector's failure to note the DOT Agency in Step 1-D was not a flaw that would require the collector to contact the DER to obtain the missing information. See our response to § 40.209.
Section 40.83How do laboratories process incoming specimens?
In paragraph (a) of this section we made a nomenclature change from “laboratory copy” to “Copy 1”. One commentor agreed with this change. The commentor wondered if DOT wanted laboratories to document the DOT Agency information from the CCF into their systems. We neither proposed that, nor will we require that.
Section 40.97What do laboratories report and how do they report it?
We revised paragraphs (a)(2)(i) and (ii), and (e)(1) of this section to require the laboratory to include the numerical values for the drug(s) or drug metabolite(s) in their report to the MRO. One commentor agreed with this change. The commentor wondered if DOT wanted laboratories to report the DOT Agency information from the CCF to the MRO. We neither proposed that, nor will we require that.
Section 40.129What are the MRO's functions in reviewing laboratory confirmed non-negative drug test results?
In paragraph (c) of this section we revised the rule text with specific instructions to the MRO on completing Step 6 of Copy 2 of the CCF. There were no comments to this section.
Section 40.163How does the MRO report drug test results?
In paragraph (c)(10) of this section we required the MRO to indicate the DOT Agency on their written report to the employer if the DOT Agency is noted on the CCF. There were two comments to this change. One commentor asked for clarification on what action a MRO is to take if the DOT Agency is not noted on the CCF. The other commentor disagreed with the MRO including the DOT Agency on the result report to the employer for the following reasons: (1) The absence of the DOT Agency being marked on the CCF is not a flaw requiring corrective action, (2) some service agents may view the absence of the DOT Agency information as an item that requires corrective action by the collector, (3) there is no current requirement for the service provider's information system to capture this data element, (4) some service agents may view this change as a requirement for the laboratory to include the DOT Agency information on their electronic reports to the MRO, and (5) the DOT Agency information would be on the employer's copy of the CCF.
Regarding the comment asking for clarification on what action a MRO is to take if the DOT Agency is not noted on the CCF, the MRO is not to delay the medical review process and report the verified result to the employer. As we said in the IFR, “* * *the laboratory and MRO should note that the testing authority box was not checked and continue with processing, testing, verifying, and reporting the specimen result, as appropriate”. [75 FR 59106] Regarding the comment to not including the DOT Agency on the result report to the employer, we agree that the designation adds nothing to the employer's knowledge of the test outcome. We have removed the requirement from the rule text.
Section 40.187What does the MRO do with split specimen laboratory results?
In paragraph (f) of this section, we revised the rule text on how a MRO is to document split specimen test results. There were no comments to this section.
Section 40.191What is a refusal to take a DOT drug test, and what are the consequences?
In paragraph (d)(2) of this section we revised the rule text on how a MRO is to document a “Refusal to Test”. There were no comments this section.
Section 40.193What happens when an employee does not provide a sufficient amount of urine for a drug test?
In paragraph (d)(2)(i) of this section we revised the rule text on how a MRO is to complete Step 6 on Copy 2 of the CCF when recording a “Refusal to Test”. There were no comments to this section.
Section 40.203What problems cause a drug test to be cancelled unless they are corrected?
In paragraph (d)(2) of this section we made a nomenclature change from “laboratory copy” to “Copy 1”. In paragraph (d)(3) we revised the time period during which the use of an expired form would not cause the test to be canceled. One commentor did “* * *not believe that use of an expired CCF should result in a cancelled test—especially in a post-accident testing situation.” The commentor suggests, as they did in an earlier comment, that use of the old CCF be permitted until its expiration date of November 30, 2011 and that use after that date be considered a “correctable flaw”. See our response to § 40.45.
Section 40.209What procedural problems do not result in the cancellation of a test and do not require corrective action?
We revised paragraph (b)(1) of this section to say that omitting the DOT Agency in Step 1-D of the CCF would be an administrative mistake that would not result in the cancellation of a test and would not require corrective action. One commentor, a large laboratory, agreed that omitting the DOT Agency in Step 1-D of the CCF should be a mistake that would not require corrective action. Another commentor, a national association, asked for clarification on what documentation a collector, laboratory, MRO or other person administering the drug testing process must maintain when the DOT Agency was not identified on the CCF.
Another commentor, a large third party administrator, wanted to bring a discrepancy to our attention. Specifically, the commentor noticed a discrepancy between the title of this section in the IFR “What procedural problems do not result in the cancellation of a test and do not require corrective action?” and the title of this section in the 2001 final rule [66 FR 41954] “What procedural problems do not result in the cancellation of a test and do not require correction?”
Regarding the comment asking for clarification on documenting the omission of the DOT Agency in Step 1-D, we believe the plain language of the rule text is self explanatory. Nevertheless, we will point out that laboratories and MROs should document this omission as they have been documenting similar omissions (the transposition of an employee's social security number or employer ID number) in the past. As we stated in the IFR, “* * *the laboratory and MRO should note that the testing authority box was not checked and continue with processing, testing, verifying, and reporting the specimen result, as appropriate”. Furthermore, there is no requirement for the collector to provide a ‘memorandum for record' to anyone after the fact to indicate the DOT Agency. The regulation requires the employer to provide this information to the collector and the information is to be recorded on the CCF. As a reminder to MROs and employers, it is important for you to know the regulating DOT Agency since there may be DOT Agency specific requirements you must fulfill ( e.g., reporting medical qualifications or non-negative results to a DOT Agency). Not complying with a DOT Agency's regulatory requirement because the DOT Agency want not indicated on the CCF does not mitigate your regulatory responsibilities.
The Department would also like to remind employers, C/TPAs and collectors that although omitting the DOT Agency on the CCF would not cancel the test or require corrective action, this type of error may subject them to enforcement action under DOT Agency regulations or action under the Public Interest Exclusion if it becomes a recurring issue.
Regarding the comment about the typographical discrepancy, the commentor is correct. However, we will leave the title of this section as printed in the IFR, because we believe it reads better and reflects the intent expressed in the 2001 preamble. [66 FR 41948]
Section 40.355What limitations apply to the activities of service agents?
In paragraph (l) of this section we made a nomenclature change from “laboratory copy” to “Copy 1”. One commentor asked for guidance on whether transmitting only Copy 1 to the laboratory is still applicable since collectors are being instructed by the laboratory to fax the MRO copy to a fax server at the lab.
In this section, the Department only changed the nomenclature from “laboratory copy” to “Copy 1”. The requirement for collectors to send Copy 1 to the laboratory did not change.
Regulatory Analyses and Notices
The statutory authority for this rule derives from the Omnibus Transportation Employee Testing Act of 1991 (49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 54101 et seq. ) and the Department of Transportation Act (49 U.S.C. 322).
This final rule is not significant for purposes of Executive Order 12866 or the DOT's regulatory policies and procedures. The rule finalizes the authorization and procedures for using the new CCF for DOT-required drug tests and makes a technical amendment to correct an inadvertent oversight in a previous rulemaking. This rule does not increase costs on regulated parties because it authorizes regulated employers to continue using the old CCF for an additional fourteen months, until November 30, 2011. After this date, the revised CCF must be used. This allows employers to use their current supply of old CCFs rather than discarding them. The rule does not impose new burdens on any parties. While small entities are among those who may use the revised CCF, the Department certifies, under the Regulatory Flexibility Act, that this rule does not have a significant economic impact on a substantial number of small entities.
The Department finds good cause to make this rule final immediately upon publication. The basis of this determination is that, under the present interim final rule, drug tests recorded on the old version of the CCF would have to be cancelled beginning October 1, 2011. Laboratories and other program participants commented that because of the large numbers of old forms still being used, this date would result in large numbers of cancellations of otherwise valid tests. By making this rule change effective before October 1, the Department will prevent this unfortunate result and allow program participants to further exhaust stocks of the old version of the form for another four months. This will make program administration considerably smoother.
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 September 22, 2011, at Washington DC.
Secretary of Transportation.
Accordingly, the Interim Final Rule amending 49 CFR part 40 which was published at 75 CFR 59105 on September 27, 2010, is adopted as final with the following changes:
PART 40—PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL TESTING PROGRAMS
1. The authority citation for 49 CFR part 40 continues to read as follows:
49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 54101 et seq.
2. In § 40.3 revise the definition of “Continuing education” to read as follows:
Continuing education. Training for substance abuse professionals (SAPs) who have completed qualification training and are performing SAP functions, designed to keep SAPs current on changes and developments in the DOT drug and alcohol testing program.
3. In § 40.45, revise paragraph (b) to read as follows:
(b) You must not use a non-Federal form or an expired CCF to conduct a DOT urine collection. As a laboratory, C/TPA or other party that provides CCFs to employers, collection sites, or other customers, you must not provide copies of an expired CCF to these participants. You must also affirmatively notify these participants that they must not use an expired CCF (e.g., that after November 30, 2011, they must not use an expired CCF for DOT urine collections).
4. In § 40.163:
a. Paragraph (c)(8) is amended by removing the semi-colon at the end and adding “; and” in its place.
b. Paragraph (c)(9) is amended by removing “; and” and adding a period in its place.
c. Remove paragraph (c)(10).
5. In § 40.203, paragraph (d)(3) is revised, to read as follows:
(d) * * *
(3) The collector uses a non-Federal form or an expired CCF for the test. This flaw may be corrected through the procedure set forth in § 40.205(b)(2), provided that the collection testing process has been conducted in accordance with the procedures of this part in an HHS-certified laboratory. During the period of October 1, 2010-November 30, 2011, you are not required to cancel a test because of the use of an old CCF. Beginning December 1, 2011, if the problem is not corrected, you must cancel the test.
[FR Doc. 2011-24818 Filed 9-26-11; 8:45 am]
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