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Office of the Secretary of Transportation
SUMMARY: The Department of Health and Human Services recently issued a new Federal Drug Testing Custody and Control Form for use in both the Federal employee and Department of Transportation drug testing programs. In order to accommodate the form's use within our transportation industry program, the Department is making a few necessary regulation changes in order for collectors, laboratories, and Medical Review Officers to know how to use the new form. The form's use is authorized beginning October 1, 2010. The Department is also making a technical amendment to its drug testing procedures. The purpose of the technical amendment is to add a provision of the rule which was inadvertently omitted from the final rule in August 2010.
EFFECTIVE DATE: The rule is effective October 1, 2010. Comments to this interim final rule should be submitted by October 27, 2010. Late-filed comments will be considered to the extent practicable.
ADDRESSES: To ensure that you do not duplicate your docket submissions, please submit them by only one of the following means:
* Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for submitting comments.
* Mail: Docket Management Facility, U.S. Department of Transportation, 1200 New Jersey Ave., SE., West Building Ground Floor Room W12-140, Washington, DC 20590-0001;
* Hand Delivery: West Building Ground Floor Room W12-140, 1200 New Jersey Ave., SE., between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The telephone number is 202-366-9329;
Instructions: You must include the agency name and docket number DOT-OST-2010-0161 or the Regulatory Identification Number (2105-AE03) for the rulemaking at the beginning of your comments. All comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
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 [email protected] (e-mail).
SUPPLEMENTARY INFORMATION: All urine specimens collected under the Department of Transportation (DOT) drug testing regulation, 49 CFR Part 40, must be collected using chain-of-custody procedures that incorporate the use of the Federal Drug Testing Custody and Control Form (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] 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. Recently, HHS announced the new CCF in the Federal Register [75 FR 41488] which has an effective date of October 1, 2010.
The following items in the revised CCF are worth noting for the DOT transportation industry drug testing program:
(1) In Step 1 of the CCF, the Federal testing authorities--HHS; DOT; and Nuclear Regulatory Commission (NRC)--are noted, with further specificity for the DOT Agencies--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/ --also noted;
FOOTNOTE 1 For purposes of following the requirements of 49 CFR Part 40, " DOT, The Department, DOT Agency" is defined, at 40.3, to include the United States Coast Guard. END FOOTNOTE
(2) In Step 5A on Copy 1 of the CCF, the new drug analytes MDMA, MDA, and MDEA are added, as are "[delta]9-THCA" after "Marijuana Metabolite" and "BZE" after "Cocaine Metabolite" to specify the drug analytes;
(3) In Step 6 on Copy 2 of the CCF, a line has been included on which the Medical Review Officer (MRO) would write the drug for which a positive result is verified, and a new line item "other" was added to assist the MRO in documenting other "refusal to test" situations--for example, when there is no legitimate medical explanation for the employee providing an insufficient amount of urine;
(4) In Step 7 on Copy 2 of the CCF, a box has been added for the MRO to check if the split specimen is reported as cancelled; and
(5) On the reverse side of Copy 5--the "Donor Copy"--of the CCF, are the revised instructions for completing the CCF.
Because HHS sought and received comments on the form and its use, we seek only to receive comments on the actual implementation of the new CCF, and not on the form itself.
In addition, the technical amendment is intended to address an omission which has been called to our attention since the publication of the Department's final rule in August 2010 [75 FR 49850] which was intended to create consistency with many of the new drug testing requirements established by HHS. Specifically, the HHS Guidelines require laboratories to report the concentration of the drug or drug metabolite for a positive result to the MRO. This was omitted from our rule text in the section that directs what laboratories are to report and how they are to report it. We have amended the rule text to reflect this requirement.
Implementation Guidance
DOT-regulated employers and their service agents are authorized to begin use of the new CCF on October 1, 2010. However, we recognize there will be large supplies of old CCFs available after the start date. To avoid wasting the old forms, the Department will permit use of the old CCF until September 30, 2011. After this date, collectors and laboratories are not to use any of the old CCFs in the DOT testing program. The rule text has been changed to reflect this one-full-year transition period from old CCF to new CCF.
However, when the old CCF is used on or before September 30, 2011, the collector will need to write in the specific DOT Agency under which the specimen is collected and must do so in the remarks section in Step 2 on Copy 1 of the CCF. This DOT Agency designation is a new feature in the new CCF. So, if an old CCF is used and the employee's specimen is collected under, for example, authority of the FMCSA regulation, the collector will write in "DOT--FMCSA" in the remarks section in Step 2 of the CCF.
Likewise, when an old CCF is used on or before September 30, 2011, before transmitting a confirmed positive drug test for MDMA, MDA, or MDEA, as appropriate, to the MRO, the laboratory--in addition to checking the "positive" box--must write in the specific MDMA, MDA, or MDEA analyte in the "Remarks" section in Step 5-A of Copy 1 of the CCF.
Like now, use of a CCF past its expiration date will not be a fatal flaw. Use of the old CCF after September 30, 2011, must be corrected using the procedures at SEC 40.205(b)(2).
Regarding the completion of the new Step 1-D of the CCF, the Department would like to emphasize that neither the employer nor the collector should find it difficult to complete this new data item. DOT-regulated employers and their Consortium/Third Party Administrators (C/TPAs) currently provide the collector and the collection site with specific instructions--the test reason, 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), among others. Adding one additional data element to what is already provided by employers or their C/TPAs to collectors should not prove significantly difficult. An employer and its C/TPA should be readily aware of the DOT Agency regulating the employee's safety-sensitive duties. We have added a new SEC 40.14 to put into one place the items that employers and their C/TPAs have been routinely providing collectors, and if they have not been doing so, the information they should have always been providing collectors, in addition to this new requirement for DOT Agency designations.
If the information in Step 1-D of the CCF is not completed, the laboratory will not delay testing the specimen and reporting the confirmed result to the MRO. Similarly, the MRO will not delay the medical review process and reporting the verified result to the employer. The Department believes 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. To reduce the potential failure of the collector to check the appropriate box in Step 1-D, the Department will permit the checkmark to be pre-printed in the appropriate box prior to the collection. We amended our rule text to reflect these situations.
As more of the DOT Agencies go toward having employee drug testing violations reported to them, these designations will prove invaluable to the process.
Regarding Step 6 of Copy 2 of the CCF, HHS provided more space for identifying the positive drug(s) and a new line item "Other" was added to assist the MRO in documenting other "Refusal to Test" situations--for example, when there is no legitimate medical explanation for the employee providing an insufficient amount of urine. In Step 7 of Copy 2 of the CCF, HHS added a box for "Test Cancelled" for the MRO to check when a test is cancelled if a split specimen fails to reconfirm. We amended our rule text to reflect these modifications. As a reminder to MROs, the "Test Cancelled" box should only be used when the split fails to reconfirm for all the results verified and reported for the primary specimen.
--This is a summary of a Federal Register article originally published on the page number listed below--
Interim Final rule.
CFR Part: "49 CFR Part 40"
RIN Number: "RIN 2105-AE03"
Citation: "75 FR 59105"
Document Number: "Docket DOT-OST-2010-0161"
Federal Register Page Number: "59105"
"Rules and Regulations"
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