Document ID: DOT-OST-2015-0045-0001
Agency: dot
Document Type: Rule
Title: Use of Electronic Chain of Custody and Control Form in DOT-Regulated Drug Testing Programs
Posted Date: 2015-04-13T04:00Z

[Federal Register Volume 80, Number 70 (Monday, April 13, 2015)]
[Rules and Regulations]
[Pages 19551-19553]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-08256]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[Docket No. OST-2015-0045]
RIN 2105-AE35

Use of Electronic Chain of Custody and Control Form in DOT-
Regulated Drug Testing Programs

AGENCY: Office of the Secretary of Transportation (OST), U.S. 
Department of Transportation (DOT).

ACTION: Final rule.

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SUMMARY: This action amends the U.S. Department of Transportation's 
(DOT) regulations to incorporate changes to the Substance Abuse and 
Mental Health Services Administration's (SAMHSA) chain of custody and 
control form (CCF) recently approved by the Office of Management and 
Budget (OMB). Specifically, this rulemaking expands the DOT's 
definition of the CCF to include both paper and electronic forms.

DATES: This final rule is effective on April 13, 2015.

FOR FURTHER INFORMATION CONTACT:  For technical questions about this 
action, contact Mark Snider, Office of Drug and Alcohol Policy and 
Compliance, 1200 New Jersey Ave. SE., Washington, DC 20590; telephone: 
(202) 366-3784; email: ODAPCWebMail@dot.gov.

SUPPLEMENTARY INFORMATION: 

Good Cause for Immediate Adoption

    Section 553(b)(3)(B) of title 5, U.S. Code, authorizes agencies to 
dispense with notice and comment procedures for rules when the agency 
for ``good cause'' finds that those procedures are ``impracticable, 
unnecessary, or contrary to the public interest.'' In this instance, 
the DOT finds that notice and public comment to this immediately 
adopted final rule, as well as any delay in the effective date of this 
rule, is unnecessary, given that the electronic CCF (eCCF) has been 
approved for use by OMB and the DOT is bound by statute to follow 
SAMHSA's chain of custody and control procedures, to include use of an 
OMB-approved CCF.

I. Authority for This Rulemaking

    This rulemaking is promulgated pursuant to the Omnibus 
Transportation Employee Testing Act (OTETA) of 1991 (Pub. L. 102-143, 
105 Stat. 952, (Oct. 28, 1991)).

II. Background

    The Federal Workplace Drug Testing Program was established by 
Executive Order 12564 on September 15, 1986, and further mandated by 
Congress in section 503 of Public Law 100-71 (July 11, 1987). The 
Department of Health and Human Services (HHS), in developing the 
program, created a comprehensive set of standards for the Federal 
workplace drug testing program, including chain of custody procedures 
designed to ensure the integrity and security of specimens from the 
time the specimen is collected until the time the testing results are 
reported by the laboratory. To satisfy the congressional mandate, HHS 
first issued its mandatory guidelines on April 11, 1988, and in doing 
so, created the uniform CCF. The CCF is the tool by which agencies and

[[Page 19552]]

participants in the testing process are assured that the specimen 
collected is actually that of the tested employee. At this time, DOT 
developed its controlled substance program, following in large part the 
mandatory guidelines set forth by HHS.
    On October 28, 1991, Congress passed OTETA, which codified the 
DOT's controlled substance testing program for its regulated entities 
and added a requirement to develop an alcohol testing program. In 
codifying the DOT program, Congress directed the Department to continue 
to ``incorporate the [HHS] scientific and technical guidelines dated 
April 11, 1988, and any amendments to those guidelines, including 
mandatory guidelines establishing . . . strict procedures governing the 
chain of custody of specimens collected for controlled substances 
testing.'' See Pub. L. 102-143. As a result of this mandate, the DOT 
has required its regulated entities to use the CCF, as developed by HHS 
and approved by OMB. Historically, the CCF only has been available for 
use in paper form. On May 28, 2014, OMB approved the use of both a 
paper form CCF and an eCCF under the HHS Mandatory Guidelines. This 
final rule is necessary to expand the DOT's definition of the CCF to 
include the OMB-approved eCCF.
    As noted above, the CCF is used to identify a specimen and to 
document its handling at the collection site. The paper CCF is a 
carbonless form consisting of 5 copies as follows:

Copy 1 Test Facility Copy
Copy 2 Medical Review Officer Copy
Copy 3 Collector Copy
Copy 4 Employer Copy
Copy 5 Donor Copy

The eCCF requires the same collection of information and distribution 
of information to the relevant parties as the paper CCF requires. With 
the approved eCCF, HHS is not requiring collection of any new or 
different information. The only change from the paper CCF to the eCCF 
is the mechanism for collecting and transmitting the requisite 
information. Before implementing an eCCF, HHS-certified laboratories 
must provide a detailed plan and proposed standard operating procedures 
(SOPs) for SAMHSA to review and approve through SAMHSA's National 
Laboratory Certification Program (NLCP). The review of validation 
records, specimen records, SOPs, staff training records, and practices 
associated with the eCCF will be part of the NLCP inspection process. 
Once the eCCF is approved for use through the NLCP inspection process, 
it may be used in the DOT drug testing program, as well as the Federal 
Workplace Drug Testing Program. For more information regarding this 
approval process, please contact the Department of Health and Human 
Services, Substance Abuse and Mental Health Services Administration, 
Division of Workplace Programs, National Laboratory Certification 
Program at (919) 541-7242, or via email at nlcp@rti.org.
    It is important to note that electronic signatures are not 
otherwise acceptable in Part 40. The use of the eCCF will create an 
exception so that electronic signatures will be acceptable on these 
forms only and not throughout the rest of Part 40.
    To ensure that the DOT regulations conform to SAMHSA's approved 
chain of custody and control procedures, the DOT is issuing this final 
rule to expand the current definition of the CCF in 49 CFR 40.3 to 
include all versions of the CCF as approved by OMB. We are amending 
Sec.  40.45 to explain that the 5-part form can be a paper form or an 
approved electronic form, as long as the employer ensures that security 
and confidentiality concerns are addressed. The DOT is amending Sec.  
40.73 to require entities using an eCCF to follow the eCCF procedures 
approved by SAMHSA through the NLCP inspection process.

III. Regulatory Analyses and Notices

    Changes to Federal regulations must undergo several analyses. 
First, Executive Orders 12866 and 13563 direct that each Federal agency 
shall propose or adopt a regulation only upon a reasoned determination 
that the benefits of the intended regulation justify its costs. Second, 
the Regulatory Flexibility Act of 1980 (Pub. L. 96-354), as codified in 
5 U.S.C. 601 et seq., requires agencies to analyze the economic impact 
of regulatory changes on small entities. The Paperwork Reduction Act of 
1995 (PRA) (44 U.S.C. 3501 et seq.) requires that DOT consider the 
impact of paperwork and other information collection burdens imposed on 
the public and, under the provisions of PRA section 3507(d), obtain 
approval from OMB for each collection of information it conducts, 
sponsors, or requires through regulations. Finally, section (a)(5) of 
division H of the Fiscal Year 2005 Omnibus Appropriations Act, Public 
Law 108-447, 118 Stat. 3268 (Dec. 8, 2004) and section 208 of the E-
Government Act of 2002, Public Law 107-347, 116 Stat. 2889 (Dec. 17, 
2002) requires DOT to conduct a Privacy Impact Assessment (PIA) of a 
regulation that will affect the privacy of individuals. This portion of 
the preamble summarizes the DOT's analyses of these impacts with 
respect to this final rule.

Executive Order 12866 and 13563 and DOT's Regulatory Policies and 
Procedures

    This final rule is not a significant regulatory action under 
Executive Order 12866 and 13563, as well as the Department's Regulatory 
Policies and Procedures. Its provisions make conforming amendments to 
include forms that have already been approved for use by OMB and that, 
by statute, the DOT is required to use. This rule does not propose any 
major policy changes or impose significant new costs or burdens. 
Rather, this rule is expected to reduce paperwork burdens for those 
entities that elect to use the new eCCF, as noted in SAMHSA's 
information collection request for the CCF that was approved by OMB. 
For more information, you may review SAMHSA's information collection 
request (ICR) 201307-0930-003 and supplemental information at 
www.reginfo.gov.

Regulatory Flexibility Analysis

    The Regulatory Flexibility Act of 1980 (Public Law 96-354, 
``RFA''), 5 U.S.C. 601 et seq., establishes ``as a principle of 
regulatory issuance that agencies shall endeavor, consistent with the 
objectives of the rule and of applicable statutes, to fit regulatory 
and informational requirements to the scale of the businesses, 
organizations, and governmental jurisdictions subject to regulation. To 
achieve this principle, agencies are required to solicit and consider 
flexible regulatory proposals and to explain the rationale for their 
actions to assure that such proposals are given serious 
consideration.'' The RFA covers a wide-range of small entities, 
including small businesses, not-for-profit organizations, and small 
governmental jurisdictions.
    Agencies must perform a review to determine whether a rule will 
have a significant economic impact on a substantial number of small 
entities. If the agency determines that it will, the agency must 
prepare a regulatory flexibility analysis as described in the RFA. 
However, if an agency determines that a rule is not expected to have a 
significant economic impact on a substantial number of small entities, 
section 605(b) provides that the head of the agency may so certify, and 
a regulatory flexibility analysis will not be required. The 
certification must include a statement providing the factual basis for 
this determination, and the reasoning should be clear. This final rule 
does not require entities to use an

[[Page 19553]]

eCCF. Rather, it presents another means of compliance for all entities, 
as is currently permitted under the HHS mandatory guidelines. It does 
not create additional burdens, but may alleviate some paperwork burdens 
if entities opt to use the eCCF. Thus, in accordance with 5 U.S.C. 
605(b), I certify that this rule will not have a significant economic 
impact on a substantial number of small entities.

Paperwork Reduction Act

    The PRA requires that the DOT consider the impact of paperwork and 
other information collection burdens imposed on the public. Because the 
DOT is obligated by statute to use whatever procedures and forms that 
SAMHSA adopts with respect to chain of custody and control for drug 
testing specimens, SAMHSA has accounted for the DOT burden in its 
recently approved information collection request. For more information 
regarding these burdens, you may review SAMHSA's ICR 201307-0930-003 
and supplemental information at www.reginfo.gov.

Privacy Act

    The DOT conducted a PIA of this rule as required by section 
522(a)(5) of division H of the FY 2005 Omnibus Appropriations Act, 
Public Law 108-447, 118 Stat. 3268 (Dec. 8, 2004) and section 208 of 
the E-Government Act of 2002, Public Law 107-347, 116 Stat. 2889 (Dec. 
17, 2002). The assessment considers any impacts of the final rule on 
the privacy of information in an identifiable form. In addition to the 
PIA issued by HHS in conjunction with its ICR for the approved CCF, the 
DOT issued a supplemental PIA, further explaining how the eCCF may be 
used by DOT-regulated entities and the measures that have been put into 
place to ensure not only the integrity and security of the testing 
process, but the privacy of individuals subject to testing. Copies of 
the DOT's supplemental PIA, as well as SAMHSA's PIA, have been placed 
in the docket for this rulemaking.

V. How To Obtain Additional Information

A. Rulemaking Documents

    An electronic copy of a rulemaking document may be obtained by 
using the Internet--1. Search the Federal Document Management System 
(FDMS) Portal (http://www.regulations.gov); or
    2. Access the Government Publishing Office's Web page: www.gpo.gov.

List of Subjects in 49 CFR Part 40

    Administrative practice and procedure, Drug testing, Laboratories, 
Reporting and recordkeeping requirements, Safety, Transportation.

The Amendment

    In consideration of the foregoing, the Department of Transportation 
amends part 40 of Title 49, Code of Federal Regulations, as follows:

PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL 
TESTING PROGRAMS

0
1. The authority citation for part 40 continues to read as follows:

    Authority: 49 U.S.C. 101, 102, 301, 322, 5331, 20140, 31306, and 
45101 et seq.

0
2. In Sec.  40.3 revise the definition of ``chain of custody'' to read 
as follows:

Sec.  40.3  What do the terms of this part mean?

* * * * *
    Chain of custody. The procedure used to document the handling of 
the urine specimen from the time the employee gives the specimen to the 
collector until the specimen is destroyed. This procedure uses the 
Federal Drug Testing Custody and Control Form (CCF) as approved by the 
Office of Management and Budget.
* * * * *
0
3. Amend Sec.  40.45 by revising paragraph (a) and adding paragraphs 
(c)(5) and (f) to read as follows:

Sec.  40.45  What form is used to document a DOT urine collection?

    (a) The Federal Drug Testing Custody and Control Form (CCF) must be 
used to document every urine collection required by the DOT drug 
testing program. You may view this form on the Department's Web site 
(http://www.dot.gov/odapc) or the HHS Web site (http://www.workplace.samhsa.gov).
* * * * *
    (c) * * *
    (5) When using an electronic CCF, you must establish adequate 
confidentiality and security measures to ensure that confidential 
employee records are not available to unauthorized persons. This 
includes protecting the physical security of records, access controls, 
and computer security measures to safeguard confidential data in 
electronic form.
* * * * *
    (f) An employer who uses an electronic CCF must ensure that the 
collection site, the primary and split laboratories, and MRO have 
compatible systems, and that the employee and any other program 
participants in the testing process will receive a legible copy of the 
CCF.

0
4. Amend Sec.  40.73 by revising paragraph (a) introductory text, 
redesignating paragraph (b) as paragraph (c), and adding a new 
paragraph (b) to read as follows:

Sec.  40.73  How is the collection process completed?

    (a) As the collector, when using the paper CCF, you must do the 
following things to complete the collection process. You must complete 
the steps called for in paragraphs (a)(1) through (7) of this section 
in the employee's presence.
* * * * *
    (b) As a collector, when using other forms of the CCF as approved 
by the Office of Management and Budget, you must follow the procedures 
approved for that form.
    (c) As a collector or collection site, you must ensure that each 
specimen you collect is shipped to a laboratory as quickly as possible, 
but in any case, within 24 hours or during the next business day.
* * * * *

    Issued under the authority provided in Pub. L. 102-143, in 
Washington, DC, on April 6, 2015.
Anthony R. Foxx,
Secretary of Transportation.
[FR Doc. 2015-08256 Filed 4-10-15; 8:45 am]
 BILLING CODE 4910-9X-P