[Federal Register Volume 89, Number 199 (Tuesday, October 15, 2024)]
[Proposed Rules]
[Pages 82957-82968]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-23427]
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DEPARTMENT OF TRANSPORTATION
Office of the Secretary
49 CFR Part 40
Pipeline and Hazardous Materials Safety Administration
49 CFR Part 199
[Docket DOT-OST-2022-0027]
RIN 2105-AF01
Electronic Signatures, Forms and Storage for Drug and Alcohol
Testing Records
AGENCY: Office of the Secretary, Department of Transportation (DOT).
ACTION: Notice of proposed rulemaking (NPRM).
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SUMMARY: The Department of Transportation (DOT or Department) proposes
to amend its regulations for conducting workplace drug and alcohol
testing for the federally regulated transportation industry to allow,
but not require, electronic signatures on documents required to be
created and utilized under the regulations, the use of electronic
versions of forms, and the electronic storage of forms and data. The
regulatory changes would apply to DOT-regulated employers and their
contractors (``service agents'') who administer their DOT-regulated
drug and alcohol testing programs. Currently, employers and their
service agents must use, sign and store paper documents exclusively,
unless the employer is utilizing a laboratory's electronic Federal Drug
Testing Custody and Control Form (electronic CCF) system that has been
approved by the Department of Health and Human Services (HHS). DOT is
required by statute to amend its regulations to authorize, to the
extent practicable, the use of electronic signatures or digital
signatures executed to electronic forms instead of traditional
handwritten signatures executed on paper forms. This rulemaking also
responds to an April 2, 2020, petition for rulemaking from DISA Global
Solutions, Inc. (DISA), requesting that DOT regulations be amended to
allow the use of an electronic version of the alcohol testing form
(ATF) for DOT-authorized alcohol testing. The proposed regulatory
amendments are expected to provide additional flexibility and reduced
costs for the industry while maintaining the integrity and
confidentiality requirements of the drug and alcohol testing
regulations. In addition, DOT proposes to amend the Pipeline and
Hazardous Materials Safety Administration (PHMSA) regulation for
conformity and to make other miscellaneous technical changes and
corrections.
DATES: Comments on this NPRM must be received on or before December 16,
2024.
ADDRESSES: You may submit comments identified by Docket Number DOT-OST-
2022-0027 using any of the following methods:
Federal eRulemaking Portal: Go to https://www.regulations.gov/docket/DOT-OST-2022-0027/document. Follow the
online instructions for submitting comments.
Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m.
and 5 p.m. ET, Monday through Friday, except Federal holidays. To be
sure someone is there to help you, please call (202) 366-9317 or (202)
366-9826 before visiting Dockets Operations.
Fax: 202-493-2251.
To avoid duplication, please use only one of these methods. See the
``Public Participation and Request for Comments'' portion of the
SUPPLEMENTARY INFORMATION section for instructions on submitting
comments, including collection of information comments for the Office
of Information and Regulatory Affairs, Office of Management and Budget
(OMB).
FOR FURTHER INFORMATION CONTACT: Mike Huntley, Office of Drug and
Alcohol Policy and Compliance, 1200 New Jersey Avenue SE, Washington,
DC 20590; telephone number 202-366-3784; [email protected]. If you
have questions on viewing or submitting material to the docket, contact
Docket Services, telephone (202) 366-9826.
SUPPLEMENTARY INFORMATION: This NPRM is organized as follows:
I. Executive Summary
II. Public Participation and Request for Comments
[[Page 82958]]
A. Submitting Comments
B. Viewing Comments and Documents
C. Privacy Act
III. Legal Basis for the Rulemaking
IV. Background
V. Advance Notice of Proposed Rulemaking (ANPRM) Overview
VI. Federal Motor Carrier Safety Administration (FMCSA) Rulemaking
on Electronic Documents and Signatures
VII. Amending Part 40 To Permit Electronic Documents and Signatures
VIII. Electronic ATF
IX. Section-by-Section Analysis
X. Regulatory Analyses and Notices
I. Executive Summary
Purpose and Summary of the Major Provisions
This proposed rule would establish parity between paper and
electronic documents and signatures and expand businesses' and
individuals' ability to use electronic methods to comply with the
Department's drug and alcohol testing regulation, 49 CFR part 40,
``Procedures for Transportation Workplace Drug and Alcohol Testing
Programs'' (part 40). Businesses and individuals subject to part 40
would continue to have the choice to use paper documents and
traditional ``wet'' signatures. This proposed rule would also modify
references to recordkeeping and reporting methods throughout part 40 to
make them technologically neutral.
This proposed rulemaking responds to a statutory mandate set forth
in section 8108 of the Fighting Opioid Abuse in Transportation Act,
part of the SUPPORT for Patients and Communities Act, Public Law 115-
271 (see 49 U.S.C. 322 note). The proposed rulemaking would take action
consistent with the Government Paperwork Elimination Act (GPEA)
(division C, title XVII, secs. 1701-1710, Pub. L. 105-277) and the
Electronic Signatures in Global and National Commerce Act (E-SIGN)
(Pub. L. 106-229) with regard to DOT's part 40 regulations.
II. Public Participation and Request for Comments
A. Submitting Comments
If you submit a comment, please include the docket number for this
NPRM (Docket No. DOT-OST-2022-0027), indicate the specific section of
this document to which each comment applies, and provide a reason for
each suggestion or recommendation. You may submit your comments and
material online or by fax, mail, or hand delivery, but please use only
one of these means. The Office of the Secretary (OST) recommends that
you include your name and a mailing address, an email address, or a
phone number in a cover letter or an email so that OST can contact you
if there are questions regarding your submission.
To submit your comment online, go to https://www.regulations.gov/docket/DOT-OST-2022-0027/document, click on this NPRM, click
``Comment,'' and type your comment into the text box on the following
screen.
If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the facility, please enclose a stamped,
self-addressed postcard or envelope.
OST will consider all comments and material received during the
comment period in determining how to proceed with any final rule.
B. Viewing Comments and Documents
To view comments, as well as any documents mentioned in this
preamble as available in the docket, go to https://www.regulations.gov.
Insert the docket number, DOT-OST-2022-0027, in the keyword box, and
click ``Search.'' Next, click the ``Open Docket Folder'' button and
choose the document to review. If you do not have access to the
internet, you may view the docket online by visiting the Docket
Management Facility in Room W12-140 on the ground floor of the DOT West
Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001, between
9 a.m. and 5 p.m. ET, Monday through Friday, except Federal holidays.
To be sure someone is there to help you, please call (202) 366-9317 or
(202) 366-9826 before visiting the Docket Management Facility.
C. Privacy Act
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its rulemaking process. DOT posts these
comments, without edit, including any personal information the
commenter provides, to www.regulations.gov, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at https://www.transportation.gov/individuals/privacy/privacy-act-system-records-notices under the heading of ``Department-Wide System of Records
Notices''.
III. Legal Basis for the Rulemaking
This rulemaking is promulgated under the authority enacted in the
Omnibus Transportation Employee Testing Act of 1991 (OTETA) (Pub. L.
102-143, tit. V, 105 Stat. 952) and codified at 49 U.S.C. 45102
(aviation), 49 U.S.C. 20140 (rail), 49 U.S.C. 31306 (motor carrier),
and 49 U.S.C. 5331 (public transportation), as well as the Department's
authority in 49 U.S.C. 322 and the PHMSA authorities specified in the
proposed regulatory text for this action.
According to Public Law 115-271, the Secretary of Transportation is
required to ``issue a final rule revising part 40 of title 49, Code of
Federal Regulations, to authorize, to the extent practicable, the use
of electronic signatures or digital signatures executed to electronic
forms instead of traditional handwritten signatures executed on paper
forms.'' (49 U.S.C. 322 note) The statute set the deadline for this
action as not later than 18 months after HHS establishes a deadline for
a certified laboratory to request approval for fully electronic CCFs
(Id.) On April 7, 2022, HHS set that deadline as August 31, 2023 (87 FR
20528). HHS has extended the deadline to August 31, 2026, to enable
sufficient time for all HHS-certified laboratories to identify and
contract with an electronic CCF supplier or to develop an electronic
CCF. The deadline for DOT's regulatory amendments would therefore be
February 29, 2028.
There are two additional Federal statutes relevant to the
implementation of electronic document and signature requirements.
The Government Paperwork Elimination Act (GPEA), codified at 44
U.S.C. 3504 note,\1\ was enacted to improve customer service and
governmental efficiency through the use of information technology. The
GPEA defines an electronic signature as a method of signing an
electronic communication that: (a) identifies and authenticates a
particular person as the source of the electronic communication; and
(b) indicates such person's approval of the information contained in
the electronic communication. Id. It also requires OMB to ensure
Federal agencies provide for: (a) the option of maintaining,
submitting; or disclosing information electronically, when practicable;
and (b) the use and acceptance of electronic signatures when
practicable. The GPEA states that electronic records submitted pursuant
to procedures developed under title XVII for the submission of records
to Federal agencies and electronic signatures used in accordance with
those procedures shall not be denied legal effect, validity, or
enforceability merely because they are in electronic form. Id.
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\1\ Division C, title XVII (sec. 1701-1710) of Public Law 105-
277, 112 Stat. 2681-749, enacted on October 21, 1998.
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[[Page 82959]]
The Electronic Signatures in Global and National Commerce Act (E-
SIGN), codified at 15 U.S.C. 7001-7031,\2\ was designed to promote the
use of electronic contract formation, signatures, and recordkeeping in
private commerce by establishing legal equivalence between traditional
paper-based methods and electronic methods. The E-SIGN Act allows the
use of electronic records to satisfy any statute, regulation, or rule
of law requiring that such information be provided in writing if the
consumer has affirmatively consented to such use and has not withdrawn
consent. Specifically, the statute establishes the legal equivalence of
the following types of documents with respect to any transaction in or
affecting interstate or foreign commerce, whether in traditional paper
or electronic form: (a) contracts, (b) signatures, and (c) other
records (15 U.S.C. 7001(a)(1)).
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\2\ Public Law 106-229, 114 Stat. 464, enacted on June 30, 2000.
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IV. Background
The Department's drug and alcohol testing regulations were
promulgated at a time when the ability to sign and retain official
records electronically--now commonplace in many business segments--was
not available. Over the course of several years, we have adopted
measures that have reduced the paper documentation associated with the
drug and alcohol testing program without compromising the integrity and
confidentiality requirements of the program. In 2003, we standardized
the form for employers to report their Management Information System
(MIS) aggregate drug and alcohol testing data, as well as the specific
data collected.\3\ When creating a ONE-DOT MIS Form, we then authorized
employers to submit a single standardized form via a web portal. In
2015, we issued a final rule to allow employers, collectors,
laboratories, and medical review officers (MROs) to use the electronic
version of the Federal Drug Testing CCF in the DOT-regulated drug
testing program.\4\ That final rule also incorporated into the
regulations the requirement to establish adequate confidentiality and
security measures to ensure that confidential employee records are not
available to unauthorized persons when using the electronic CCF. We
also included language protecting the physical security of records,
access controls, and computer security measures to safeguard
confidential data in electronic form when using the electronic CCF.
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\3\ 68 FR 43946 (July 25, 2003).
\4\ 80 FR 19551 (Apr. 13, 2015).
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Consistent with the statutory mandate in 49 U.S.C. 322 note, we
propose amendments to part 40 to permit the use of electronic
signatures, forms, and records storage for drug and alcohol testing
records throughout the regulation, including the use of an electronic
ATF for DOT-authorized alcohol testing. We emphasize that electronic
signatures, forms, and records would not be required; we would continue
to allow paper, or hard-copy use with traditional ``wet signatures.''
These proposed amendments would establish parity between paper and
electronic collection and submission of information required under our
regulations (and remain compatible with applicable OMB guidance on
implementing electronic signatures \5\) by allowing further use of
electronic means and methods to comply with part 40 requirements. Many
employers and their service agents have already instituted the use of
electronic signatures, forms, and records storage for the non-DOT
regulated testing that they conduct. DOT supports this transition to a
paperless system and is committed to ensuring that the movement to a
partially or fully electronic part 40 is done to maximize program
efficiencies and reduce costs, while maintaining the integrity and
confidentiality requirements of the program.
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\5\ https://www.whitehouse.gov/wp-content/uploads/2017/11/2000-M-00-15-OMB-Guidance-on-Implementing-the-Electronic-Signatures-in-Global-and-National-Commerce-Act.pdf.
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Electronic documents would have a high degree of forensic
defensibility as long as any changes made to the document are in the
document's electronic footprint, which shows when the document or
signature, as applicable, was created; when, and if, changes were made;
who made the changes; and when, as applicable, a document was
transmitted to and received by the receiving entity. The use of
electronic forms and signatures in part 40 would help DOT-regulated
employers and their service agents improve their workflow efficiency
through faster turnaround times for required documents. Cost savings
would result through reduced printing and delivery/shipping costs, and
expedited transmission of information allowing for more timely
decisions. We believe this proposed rule, if adopted, would also
mitigate the longstanding problems (e.g., delays in processing times of
test results, cancelling of test results, etc.) associated with
illegible and lost copies of paper documents.
V. Advance Notice of Proposed Rulemaking (ANPRM) Overview
On August 5, 2022, we published an ANPRM requesting public comment
on how part 40 could be amended, as required by the statute, to allow
electronic signatures, forms, and recordkeeping (87 FR 47951). We
requested information from DOT-regulated employers and their service
agents regarding if and how they are already handling electronic
signatures, records transmission, and records storage in their non-DOT
testing programs. In addition, we requested comments and information on
appropriate performance standards, and on whether particular methods or
performance standards have been successful or unsuccessful. We also
asked a number of general questions on the potential advantages, risks,
ramifications, and required safeguards associated with the use of
electronic signatures, forms, and records in the DOT drug and alcohol
testing program. We asked questions about specific sections of part 40
that we anticipated would be affected by prospective changes to
implement electronic signatures, forms, and records. Finally, we asked
a number of questions regarding the use of an electronic ATF for DOT-
regulated alcohol tests.
We received 72 comments in response to the ANPRM, including
comments from individuals, testing laboratories, MROs, and MRO
organizations, substance abuse professionals (SAP) and SAP
organizations, and various associations representing DOT-regulated
transportation workers subject to mandatory drug and alcohol testing
under part 40.
A few individuals expressed opposition to the adoption of
electronic signatures, forms, and recordkeeping, citing concerns about
the need for the rulemaking, risk to personal information from hackers
or mismanaged electronic processes and procedures, and misuse of
electronic forms and signatures. To meet our statutory mandate and in
consideration of concerns about safeguarding personal information and
appropriate use of the information in developing the NPRM, DOT proposes
to require security measures for electronic forms and signatures used
under part 40 that are the same as those currently in place for the
electronic CCF specified in 49 CFR 40.40(c)(5).
Most commenters were supportive of changes to amend part 40 that
would permit, but not require, the use of electronic signatures, forms,
and
[[Page 82960]]
recordkeeping. Commenters supporting revisions to part 40 noted that
electronic signatures, forms, and recordkeeping are used in virtually
every industry today--including but not limited to the banking,
insurance, medical, and legal industries. Commenters supported the use
of performance standards instead of technology-specific standards to
ensure that, once established, standards do not become obsolete given
the rapidly evolving nature of information technology standards and
practices. Commenters stated that allowing electronic signatures,
forms, and recordkeeping would make the drug testing process much more
efficient and would result in cost savings. Commenters also stated that
it would be safer to store records electronically since records could
be backed-up, secured, and protected from tampering and unauthorized
access and use.
VI. Federal Motor Carrier Safety Administration (FMCSA) Rulemaking on
Electronic Documents and Signatures
In developing this NPRM, we looked to a rule promulgated by DOT's
FMCSA that permits the use of electronic methods to generate, certify,
sign, maintain, or exchange records so long as the documents accurately
reflect the required information and can be used for their intended
purpose. (83 FR 16210, Apr. 16, 2018) The rule applies to documents
that FMCSA requires entities or individuals to retain. FMCSA permits,
but does not require, anyone to satisfy FMCSA requirements by using
electronic methods to generate, maintain, or exchange documents. The
substance of the document must otherwise comply with applicable Federal
laws and FMCSA rules. FMCSA also permits, but does not require, anyone
required to sign or certify a document to do so using electronic
signatures, defined, as in the GPEA, as a method of signing an
electronic communication that: (1) identifies and authenticates a
particular person as the source of the electronic communication; and
(2) indicates such person's approval of the information contained in
the electronic communication. FMCSA allows for the use any available
technology for electronic signatures, so long as the signature
otherwise complies with FMCSA's requirements.
FMCSA adopted broad performance standards for electronic documents
and signatures--as specified in GPEA and E-SIGN--rather than detailed,
technology specific standards that would likely become obsolete with
inevitable changes in information technology standards and practices.
FMCSA's April 2018 rule has been in effect for more than five years,
and the definitions and requirements established in that rule have
stood the test of time despite the many changes that have occurred with
respect to electronic documents and signatures. We are unaware of any
FMCSA-regulated entities that have reported issues to FMCSA regarding
the use of electronic documents or signatures to meet the requirements
of the FMCSRs since the rule became effective in 2018.
VII. Amending Part 40 To Permit Electronic Documents and Signatures
In this NPRM, we propose to permit but not require electronic
documents, signatures, and recordkeeping in part 40. Additionally, we
propose a performance standard approach as opposed to establishing
technology-specific standards. Where it is possible to do so,
establishing the same or substantively similar regulatory requirements
for common issues across DOT modal agencies--such as the use of
electronic documents and signatures--helps the Department maintain a
consistent regulatory approach for those common issues.
There are currently more than 60 references to the term ``written''
in part 40, and more than 20 additional references to the term ``in
writing.'' We propose to add a definition of ``written or in writing''
in part 40, to eliminate any distinction between paper and electronic
documentation and establish technological neutrality throughout the
entirety of part 40.
FMCSA's rule does not apply to documents that individuals or
entities are required to file directly with FMCSA. In its April 2018
final rule, FMCSA explained that while industry could use electronic
signatures and submit information directly to the FMCSA in certain
situations,\6\ adapting all FMCSA systems to allow for use of
electronic signatures and submissions would significantly delay the
implementation of the rule for use by third parties as it would require
FMCSA to develop and implement technology systems to allow for direct
submission to FMCSA from regulated parties. FMCSA noted that
development of such systems could take several years, and therefore saw
no reason to make private parties' use of electronic signatures and
records retention contingent upon FMCSA's ability to receive
submissions electronically because doing so would delay potential
benefits to be gained by third parties.
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\6\ As an example, Certified Medical Examiners may use
electronic signatures, if they choose to do so, to sign medical
forms, certificates, and a new driver medication report. If FMCSA
requests these forms, they are uploaded in portable document format
(PDF) to the Medical Examiner's account associated with the National
Registry of Certified Medical Examiners for FMCSA to access.
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In contrast to FMCSA's regulations, part 40 does not require
entities or individuals to submit documents directly to the Department
except for MIS aggregate drug and alcohol testing data that employers
subject to DOT or U.S. Coast Guard (USCG) drug and alcohol testing
regulations must submit annually. Each of the various documents
required and used as part of the DOT drug and alcohol testing program
under part 40 (e.g., employee drug and alcohol testing records, MRO
reports and records, SAP reports and records) are documents that are
created by, exchanged between, and maintained by a person or entity
involved in the testing process--but are not required to be submitted
directly to DOT.
As noted earlier, and specifically with respect to the required MIS
data, we standardized the form for employers to report their aggregate
drug and alcohol testing data, as well as the specific data collected,
more than 20 years ago. At that time, we authorized employers to submit
the ONE-DOT MIS form via a web portal. Today, the Federal Aviation
Administration, FMCSA, Federal Railroad Administration, and Federal
Transit Administration permit employers to submit that same drug and
alcohol testing data via the internet, and PHMSA requires that the data
be submitted electronically. If employers submit the data
electronically via the internet, they are not required to submit a hard
copy. DOT recommends that employers have a copy of their data available
(either hard copy or in electronic format) in the event an auditor or
inspector requests a copy.
From the above, and because the only documents that part 40
requires to be submitted directly to the Department are already
permitted to be, and in some cases required to be, submitted
electronically, there is no need for us to limit the applicability of
our proposal as FMCSA did in its 2018 final rule.
Several commenters noted that they already use electronic
signatures and documents for their non-DOT drug and alcohol testing
program, and in some cases, have done so for many years. In doing so,
these commenters have had to establish appropriate confidentiality and
security measures to ensure that confidential employee records cannot
be accessed by unauthorized persons, including protecting the physical
security of records, access controls, and computer security measures to
safeguard confidential data in electronic
[[Page 82961]]
form. The same general requirements were added to the current Sec.
40.40(c)(5) when we approved the use of the electronic CCF for use in
DOT drug testing in 2015,\7\ and we propose the same requirements in
this NPRM for the use of electronic signatures, documents, and
recordkeeping throughout the entirety of part 40.
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\7\ The 2015 revisions amended then Sec. 40.45(c)(5), which was
redesignated as Sec. 40.40(c)(5) in the May 2023 final rule to
include oral fluid testing in the DOT drug testing program (88 FR
27596, May 2, 2023).
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Ensuring that confidential employee records are not available to
unauthorized persons is an important element of part 40's protections
for employees that are subject to DOT's drug and alcohol testing rules.
We believe that the failure of a service agent to provide or maintain a
secure/confidential electronic system should constitute the basis for
the Department to start a public interest exclusion (PIE) proceeding,
and propose to add this to the list of examples provided in Sec.
40.365(b).
Throughout part 40, information and documents are required to be
transmitted and/or communicated between service agents (e.g.,
collectors, screening test technicians (STTs) and breath alcohol
technicians (BATs), laboratories, MROs, SAPs, and consortium/third
party administrators (C/TPAs)), employers, and employees). Although
part 40 does not currently require the party receiving these
communications and/or documents to affirmatively confirm receipt of
such from the sender, in some instances, regardless of whether the
document is electronic or a hard copy, we believe that it may be
important for the receiving party to verify that those required
communications and/or documents were received.
For example, under Sec. 40.25, an employer intending to use an
employee to perform safety-sensitive functions must, after obtaining an
employee's written consent, request information about the employee's
drug and alcohol testing record from previous DOT-regulated employers.
After receiving a copy of the employee's written consent, the previous
employer must immediately provide the requested information to the
employer making the inquiry. If an employer is subsequently
investigated/audited by the appropriate DOT mode, it may be beneficial
for both the gaining employer and the previous employer to be able to
affirmatively demonstrate that the employee's written consent and
previous testing record were sent and received as required.
Sections 40.191(d) and 40.261(c)(1) require a collector or MRO (for
drug tests) or a BAT, STT, or a physician evaluating a ``shy lung''
situation (for alcohol tests), respectively, to--when an employee
refuses to participate in a part of the testing process--terminate the
testing process, document the refusal, and immediately and directly
notify the employer's designated employer representative (DER) by any
means that ensures the refusal notification is immediately received.
Because this notification of a refusal to an employer is of an urgent
nature, it may be advisable to require the DER to affirmatively confirm
receipt of the required notification from the collector, MRO, BAT, STT,
or physician. For example, Sec. Sec. 40.191(d) and 40.261(c)(1) could
be amended to read ``. . . immediately notify the DER by any means and
ensure that the refusal notification is immediately received''.
While we are not proposing new requirements in this NPRM regarding
confirmation of receipt in the sections discussed above (or in other
part 40 requirements), we seek comment regarding whether it may be
beneficial or advisable to do so, and if so, for which specific
sections of part 40.
VIII. Electronic ATF
The ATF has been in use in the DOT alcohol testing program since
1994 (see 59 FR 7349, Feb. 15, 1994). The ATF must be used to document
every DOT alcohol test. DOT regulations at 49 CFR 40.225 set forth the
requirements for use of the form, and 49 CFR part 40, appendix G,
contains a facsimile (reference copy) of the form. The ATF is a three-
part carbonless manifold form used by DOT-regulated employers to
document the testing event when testing employees subject to DOT
alcohol testing. When the employee is tested, both the employee and the
STT and/or the BAT will complete the ATF in various sections. The STT/
BAT documents the result(s) by either writing in the screening result
or attaching the screening and/or confirmation result printed by the
evidential breath testing devices (EBT) onto the ATF, and then sends
Copy 1 to the employer, provides Copy 2 to the employee, and retains
Copy 3 for their records.
On April 2, 2020, DISA petitioned the Department to amend part 40
to allow for the use of an electronic version of the ATF for DOT
mandated alcohol testing. In support of its petition, DISA stated that
``The requested amendment to 49 CFR part 40 will enable a parallel
process for the documentation of DOT-mandated alcohol tests aligned
with the similarly situated amendment previously approved for drug
testing.'' DISA believes that allowing the use of an electronic ATF
will result in several benefits to the industry, including ``increased
efficiency, security and accuracy in documentation of DOT alcohol
tests; paperwork reduction; improved process for conducting a DOT
alcohol test in conjunction with a DOT drug test when an electronic
version of the federal CCF is used for the drug test; reduction of
errors and omissions in the completion of the ATF; and improved
efficiency and efficacy in the transmission and record retention of
alcohol test results.''
DISA noted that non-DOT workplace breath alcohol testing has been
conducted using electronic versions of an alcohol testing form that
mirrors the DOT ATF for more than five years. Based on experience using
those electronic forms for non-DOT testing, DISA cites improved
efficiency and accuracy of documentation because: (1) employer and
employee information is entered via computer and thus not dependent on
reading and deciphering hand-written entries, (2) date time stamps of
the testing are automated and not subject to fluctuation or error, (3)
transmission of documentation on completed tests is more secure using
databases accessed only via protected password and personal
identification number (PIN) to authorized employers or their designated
agents, and (4) transmission of test result information is faster and
more secure than existing transmission options of scanning and emailing
attachments or facsimile.
DISA also noted that permitting use of an electronic ATF for DOT-
regulated alcohol testing ``will substantially reduce cost, by
eliminating the requirement for the printing and distribution of
carbonless three-ply paper ATFs. The proposed electronic ATF option
would still provide for printed paper images to be made available to
the employee, the employer, and the alcohol technician, [but]
eliminates the requirement for the more expensive carbonless 3 ply
paper ATF.''
For the reasons described by DISA in its petition, and recognizing
that significant benefits and cost reductions have resulted from use of
the electronic CCF for drug testing, we believe that it is likewise
appropriate to permit the use of electronic ATFs in part 40 for DOT-
regulated testing. Permitting but not requiring the use of an
electronic ATF would be consistent with our proposal to permit, but not
require, the use of electronic documents and signatures throughout the
entirety of part 40 as discussed above. As several commenters
[[Page 82962]]
noted, the use of an electronic ATF has been used in non-DOT testing
for 5-10 years, and the same developers of the electronic CCFs have
developed the electronic ATFs. Any electronic ATF used under part 40
for DOT-regulated employees would have to be identical in form and
content to the DOT ATF in appendix I to part 40.\8\ Just as we imposed
general confidentiality and security requirements when electronic CCFs
were permitted to be used under part 40, we believe that it is
necessary to include the same general requirements relating to the use
of electronic ATFs to ensure that confidential employee records cannot
be accessed by unauthorized persons.
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\8\ The ATF form was redesignated from appendix G to appendix I
as part of the rulemaking process culminating in the May 2023 final
rule. During that process, the form was reviewed by the public and
DOT received no comment on the form.
---------------------------------------------------------------------------
Manufacturers of EBTs and alcohol screening devices (ASD) used in
DOT alcohol tests must obtain approval from the National Highway
Traffic Safety Administration (NHTSA) and then be listed on the Office
of Drug and Alcohol Policy and Compliance's (ODAPC) website before
those devices may be used in DOT alcohol testing.
IX. PHMSA Proposed Changes
PHMSA is proposing to amend Sec. Sec. 199.3, 199.117, and 199.227
and to add Sec. 199.4 to conform to the proposed changes in part 40
and to clarify that the proposed changes in part 40 apply to part 199.
These changes will help the readers of part 199 find the applicable
regulations in part 40 with regards to the definition of terms and
record keeping requirements. We also propose to amend Sec. Sec.
199.119 and 199.229 by changing the reference of ``appendix H'' to
``appendix J'' to conform to the amendment of part 40 published on May
2, 2023.
X. Section-by-Section Analysis
Section 40.3 What do the terms used in this regulation mean?
We propose to add a definition of ``electronic signature.'' The
rule would define an electronic signature as a method of signing an
electronic communication that identifies and authenticates a particular
person as the source of the electronic communication and indicates such
person's approval of the information contained in the electronic
communication, in accordance with the Government Paperwork Elimination
Act (Pub. L. 105-277, title XVII, secs. 1701-1710, 44 U.S.C. 3504 note,
112 Stat. 2681-749). Including the specific cross reference to GPEA
would ensure that regulated entities know that we are using GPEA's
performance standard for allowing use of electronic signatures.
We propose to add a definition of ``written or in writing.'' The
rule would define written or in writing as printed, handwritten, or
typewritten either on paper or other tangible medium, or by any method
of electronic documentation that meets the requirements of 49 CFR 40.4.
This definition would eliminate any distinction between paper and
electronic methods of communication/documentation.
Section 40.4 May electronic documents and signatures be used?
We propose to add a new Sec. 40.4 that would prescribe the
requirements pertaining to electronic documents and signatures
throughout part 40.
Paragraph (a) would specify that Sec. 40.4 would apply to all
documents required by part 40, except for the CCF, as an electronic CCF
may only be used when approved by HHS and in compliance with Sec.
40.40(c)(5). As background, before an HHS-certified laboratory can use
a Federal electronic CCF for regulated specimens, the test facility
must submit a detailed plan and proposed standard operating procedures
for the electronic CCF system for HHS review and approval through the
National Laboratory Certification Program. At the current time, several
HHS-certified laboratories have received approval to use a combination
electronic/paper CCF, while four laboratories have received approval to
use a fully electronic CCF. As noted earlier, and in a separate section
of the SUPPORT Act, HHS was required to set a deadline for certified
laboratories to request approval for use of fully electronic CCFs. That
deadline is now August 31, 2026.
Paragraph (b) would permit, but not require, any person or entity
to use electronic methods to comply with any provision in part 40 that
requires a document to be signed, certified, generated, maintained, or
transmitted between parties. It would apply to all forms of written
documentation, including forms, records, notations, and other
documents. The substance of the document would otherwise have to comply
with part 40 requirements. This would establish parity between paper
and electronic documents and signatures, greatly expanding interested
parties' ability to use electronic methods to comply with the
requirements of part 40.
Paragraph (c) would permit, but not require, any entity required to
sign or certify a document to do so using electronic signatures as
defined in Sec. 40.3. The rule specifies that a person may use any
available technology so long as the signature otherwise complies with
the requirements of part 40.
Paragraph (d) would establish the minimum requirements for
electronic documents and signatures. Any electronic document or
signature would be considered the legal equivalent of a paper document
or signature if it is the functional equivalent with respect to
integrity, accuracy, and accessibility. In other words, the electronic
documents or signatures need to accurately and reliably reflect the
information in the record. They must remain accessible in a form that
could be accurately viewed or reproduced according to Agency rules. As
with any documents, paper or electronic, documents that are not
legible--for any reason--do not satisfy the Department's requirements.
Electronic documents are not to be considered the legal equivalent
of traditional paper documents if they (1) are not capable of being
retained, (2) are not used for the purpose for which they were created,
or (3) cannot be accurately reproduced for reference by any entity
entitled to access by law, for the period of time required by the
Department's recordkeeping requirements.
Paragraph (d) would also require that any electronically signed
documents must incorporate or otherwise include evidence that both
parties to the document have consented to the use of electronic
signatures, as required by the E-SIGN Act (15 U.S.C. 7001(c)).
Paragraph (e) would require that when using electronic documents
and signatures, adequate confidentiality and security measures must be
established to ensure that confidential employee records cannot be
accessed by unauthorized persons. This includes protecting the physical
security of records, access controls, and computer security measures to
safeguard confidential data in electronic form. The proposed
requirements are analogous to those established in the current Sec.
40.40(c)(5) when we approved use of the electronic CCF in part 40.
Section 40.25 Must an employer check on the drug and alcohol testing
record of employees it is intending to use to perform safety-sensitive
duties?
Currently, paragraph (g) makes it clear that the release of
information under this section must be in any written form, and the
parenthetical clarifies that this can be paper-based (written, fax) or
electronic (email). Under the proposed definition of ``written or in
writing,'' there is no distinction between paper-based and electronic
communications.
[[Page 82963]]
Because ``written or in writing'' would mean either paper or electronic
communications, we propose to remove parenthetical reference to ``fax,
email, letter'' to eliminate redundancy and confusion. All parties can
conduct their business using either paper or electronic means of
documentation and communication.
Section 40.79 How is the collection process completed?
Currently, paragraph (a)(9) of this section requires the collector
to ``fax or otherwise transmit'' Copy 2 of the CCF to the MRO and Copy
4 to the DER within 24 hours or during the next business day. We
propose to amend this section by removing reference to the methods of
transmitting receipts, so parties can choose their own medium of
communication.
Section 40.97 What do laboratories report and how do they report it?
For the same reasons explained in the discussion of Sec. 40.79, we
propose to remove the references to the methods of transmitting Copy 1
of the CCF from the laboratory to the MRO in paragraphs (c)(1) and (2)
of this section.
Section 40.111 When and how must a laboratory disclose statistical
summaries and other information it maintains?
For the same reasons explained in the discussion of Sec. 40.79, we
propose to amend paragraph (b) of this section to remove the references
to the methods of transmitting the summary or report required by this
section. Because the summary or report can be transmitted via hard copy
or electronically, there is no need to specify how it must be
transmitted. As such, we propose to amend the title of this section
accordingly.
Section 40.127 What are the MRO's functions in reviewing negative test
results?
For the same reasons explained in the discussion of Sec. 40.25, we
propose to delete the parenthetical references to ``fax, photocopy,
image'' for Copy 1 of the CCF in paragraph (c)(2) of this section.
Section 40.129 What are the MRO's functions in reviewing laboratory
confirmed non-negative test results?
For the same reasons explained in the discussion of Sec. 40.25, we
propose to delete the parenthetical references to ``fax, photocopy,
image'' for Copy 1 of the CCF in paragraph (b)(2) of this section.
Section 40.163 How does the MRO report drug test results?
For the same reasons explained in the discussion of Sec. 40.25, we
propose to remove the reference to a ``letter'' in paragraph (c) of
this section. In paragraph (e) of this section, we propose to replace
the term ``letter'' with ``written report'' for consistency with
paragraph (c).
Section 40.167 How are MRO reports of drug results transmitted to the
employer?
For the same reasons explained in the discussion of Sec. 40.25, we
propose to delete the references to ``fax, courier, mail, or
electronically'' in paragraph (c)(1) of this section.
Section 40.185 Through what methods and to whom must a laboratory
report split specimen results?
For the same reasons explained in the discussion of Sec. 40.25, we
propose to delete the references to ``fax, courier, mail, or
electronically'' in paragraph (b) of this section. In addition, because
Copy 1 of the CCF can be transmitted in writing or electronically,
there is no need to specify the methods through which it must be
transmitted. As such, we propose to amend the title of this section
accordingly.
Section 40.187 What does the MRO do with split specimen laboratory
results?
For the same reasons explained in the discussion of Sec. 40.79, we
propose to remove the references to the methods of transmitting Copy 1
of the CCF from the laboratory to the MRO in paragraph (c)(2)(iv)(C) of
this section.
Section 40.191 What is a refusal to take a DOT drug test, and what are
the consequences?
For the same reasons explained in the discussion of Sec. 40.25, we
propose to delete the parenthetical references to ``telephone or secure
fax machine'' in paragraph (d) of this section as means of transmitting
notification that an employee has refused to participate in part of the
testing process from the collector or MRO to the DER.
Section 40.193 What happens when an employee does not provide a
sufficient amount of urine for a drug test?
For the same reasons explained in the discussion of Sec. 40.25, we
propose to delete the references to ``send or fax'' as the means for
the collector to transmit copies of the CCF to the MRO and the DER in
paragraph (b)(3) of this section.
Section 40.205 How are drug test problems corrected?
For the same reasons explained in the discussion of Sec. 40.25, we
propose to delete the references to ``by fax or courier'' as the means
for a collector, laboratory, MRO, employer, or other person to supply
signed statements regarding correctable problems in a drug test in
paragraphs (b)(1) and (2) of this section.
Section 40.225 What form is used for an alcohol test?
We propose to amend this section to permit, but not require, the
use of an electronic version of the DOT ATF that is identical in form
and content to the form provided in appendix I to part 40. The
electronic ATF must be capable of capturing the electronic signatures
of the employee and the BAT and/or STT, and if an EBT provides a
separate printout of confirmation test results pursuant to Sec.
40.253(g), the electronic ATF must include that separate printout. This
section would also be amended to specify the same general
confidentiality and security measures in Sec. 40.45 relating to
electronic CCFs to ensure that confidential employee records cannot be
accessed by unauthorized persons.
Section 40.255 What happens next after the alcohol confirmation test
result?
For the same reasons explained in the discussion of Sec. 40.25, we
propose to delete the parenthetical references to ``telephone or secure
fax machine'' in paragraph (a)(5)(i) of this section as means of
transmitting results of the alcohol confirmation test from the BAT to
the DER. Similarly, there is no need to specify that Copy 1 of the ATF
may be transmitted ``in person, by telephone, or by electronic means.''
Section 40.261 What is a refusal to take an alcohol test, and what are
the consequences?
For the same reasons explained in the discussion of Sec. 40.25, we
propose to delete the parenthetical references to ``telephone or secure
fax machine'' in paragraph (c) of this section as means of transmitting
a refusal notification from a BAT, STT, or referral physician to the
DER.
Section 40.271 How are alcohol testing problems corrected?
For the same reasons explained in the discussion of Sec. 40.25, we
propose to delete the references to ``by fax or courier'' as the means
for a STT, BAT, employer, or other service agent to supply a signed
statement regarding
[[Page 82964]]
correctable flaws in an alcohol test in paragraph (b)(2) of this
section.
Section 40.365 What is the Department's policy concerning starting a
PIE proceeding?
We propose to amend this section by adding a new paragraph (b)(15)
that would identify the failure of a service agent to provide or
maintain a secure/confidential electronic system as appropriate grounds
for starting a PIE proceeding.
X. Regulatory Analyses and Notices
Executive Orders 12866, 13563, and 14094 (Regulatory Planning and
Review)
The Secretary has examined the impact of the proposed part 40
amendments under Executive Order 12866 (``Regulatory Planning and
Review''), as supplemented by Executive Order 13563 (``Improving
Regulation and Regulatory Review'') and amended by Executive Order
14094 (``Modernizing Regulatory Review''), which directs Federal
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select regulatory
approaches that maximize net benefits (including potential economic,
environmental, public health and safety, and other advantages;
distributive impacts; and equity).
According to these Executive orders, a regulatory action is
``significant'' if it meets any one of a number of specified
conditions, including having an annual effect on the economy of $200
million or more, as adjusted every three years by the Office of
Information and Regulatory Affairs (OIRA); adversely affecting in a
material way a sector of the economy, competition, or jobs; or if it
raises novel legal or policy issues. The proposed amendments, which
would allow the use of electronic documents and signatures, do not meet
the Executive order's criteria for being a significant rule.
Consequently, OMB has determined that the rulemaking action is not
significant under the Executive order.
The proposed rule responds to the statutory mandate set forth in
Section 8108 of the Fighting Opioid Abuse in Transportation Act, part
of the SUPPORT for Patients and Communities Act, Public Law 115-271.
The proposed rule would not impose new requirements on the industry;
rather, it would simply permit--but not require--regulated entities to
use electronic signatures, forms, and recordkeeping, and remove
outdated and obsolete references in the regulatory text. The proposed
rule would not impose new costs on the industry because regulated
entities would be allowed to choose to continue to use paper-based
documents as they had before. The benefits of the rule would stem from
savings in paper and printing expense and other efficiency gains.
Examples of documents affected by this rule include, but are not
limited to, records of a prospective employee's drug and alcohol
testing history that employers must obtain prior to permitting that
employee to perform safety-sensitive duties, MRO records and reports,
SAP records and reports, and ATFs. While there is no way to estimate
how many entities or individuals would change their practices given the
new options, or how many documents would be affected, several
commenters to the ANPRM stated that they have been using electronic
documents and signatures in their non-DOT drug and alcohol testing
programs for many years. While neither the benefits nor the costs of
this rule can be reliably estimated, we expect this proposed rule to
provide flexibility to the industry. Under this proposed rule,
regulated entities would have the flexibility to conduct business using
either electronic or traditional paper-based methods. We also expect
regulated entities to choose technologies that would maximize benefits
in accordance with their individual needs and circumstances.
Regulatory Flexibility Act and Small Business Regulatory Enforcement
Fairness Act (SBREFA)
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et seq.)
requires Federal agencies to consider the effects of their regulatory
actions on small businesses and other small entities and minimize any
significant economic impact. The term ``small entities'' comprises
small businesses and not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with a population of less than 50,000.
For this rulemaking, potentially affected small entities include drug
testing companies (U.S. Small Business Administration (SBA) North
American Industry Classification System (NAICS) Sector 54
(Professional, Scientific and Technical Services), Code 541380 (Testing
Laboratories and Services)) as well as DOT-regulated entities (SBA
NAICS Sectors 48-49 (Transportation and Warehousing)).
The Department does not expect that the proposed rule would have a
significant economic impact on a substantial number of small entities.
The proposed rule, if adopted, would increase flexibility for all
small-entity transportation employers and their service agents by
allowing them to use electronic documents, signatures, and
recordkeeping to meet part 40 requirements. Use of electronic
documents, electronic signatures, and electronic recordkeeping would be
voluntary for affected small entities, which will provide added
flexibility to these entities in meeting the part 40 requirements. For
these reasons, and as explained in more detail in the preamble to this
proposed rule, the Secretary certifies that the proposed rule would not
have a significant economic impact on a substantial number of small
entities within the meaning of the Regulatory Flexibility Act.
Consequently, an initial regulatory flexibility analysis is not
required for this proposed rule.
Unfunded Mandates
The Secretary has examined the impact of the final rule under the
Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This NPRM
does not trigger the requirement for a written statement under sec.
202(a) of the UMRA because this rulemaking does not impose a mandate
that results in an expenditure of $100 million (adjusted annually for
inflation) or more by either State, local, and tribal governments in
the aggregate or by the private sector in any one year. In fact, by
providing an alternative to traditional paper-based records, the
proposed rule would be expected to reduce costs to regulated parties,
including State and local entities (e.g., public transit authorities,
and public works departments) whose employees are subject to testing
and that choose to use electronic documents as opposed to paper-based
documents.
Environmental Impact
The DOT has analyzed the environmental impacts of this action
pursuant to the National Environmental Policy Act of 1969 (NEPA) (42
U.S.C. 4321 et seq.) and has determined that it is categorically
excluded pursuant to DOT Order 5610.1C, ``Procedures for Considering
Environmental Impacts'' (44 FR 56420, October 1, 1979). Categorical
exclusions are actions identified in an agency's NEPA implementing
procedures that do not normally have a significant impact on the
environment and therefore do not require either an environmental
assessment (EA) or environmental impact statement (EIS). This proposed
rule would amend the transportation industry drug testing program
procedures regulation to permit the use
[[Page 82965]]
of electronic documents, signatures, and recordkeeping. This action is
covered by the categorical exclusion listed at 23 CFR 771.118(c)(4),
``[p]lanning and administrative activities that do not involve or lead
directly to construction, such as: . . . promulgation of rules,
regulations, directives . . .'' The Department does not anticipate any
environmental impacts, and there are no extraordinary circumstances
present in connection with this rulemaking.
Executive Order 13132: Federalism
The Secretary has analyzed the final rule in accordance with
Executive Order 13132: Federalism. Executive Order 13132 requires
Federal agencies to carefully examine actions to determine if they
contain policies that have federalism implications or that preempt
State law. As defined in the order, ``policies that have federalism
implications'' refer to regulations, legislative comments or proposed
legislation, and other policy statements or actions that have
substantial direct effects on the States, on the relationship between
the National Government and the States, or on the distribution of power
and responsibilities among the various levels of government.
Most of the regulated parties under the Department's drug testing
program are private entities. Some regulated entities are public
entities (e.g., transit authorities and public works departments);
however, as noted above, this proposal would reduce costs of the
Department's drug testing program and provide additional flexibility
for regulated parties. Accordingly, the Secretary has determined that
the proposed rule, which would allow but not require use of electronic
signatures and recordkeeping, does not contain policies that have
federalism implications.
Executive Order 13175: Consultation and Coordination With Indian Tribal
Governments
Executive Order 13175 (65 FR 67249, November 6, 2000) requires
Federal agencies to develop an accountable process to ensure
``meaningful and timely input by tribal officials in the development of
regulatory policies that have tribal implications.'' ``Policies that
have tribal implications'' as defined in the Executive order, include
regulations that have ``substantial direct effects on one or more
Indian tribes, on the relationship between the Federal government and
the Indian tribes, or on the distribution of power and responsibilities
between the Federal government and Indian tribes.'' This proposed rule
does not have tribal implications. The proposed rule will also not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Paperwork Reduction Act
The Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) (PRA)
requires that DOT consider the impact of paperwork and other
information collection burdens imposed on the public. This proposed
rule would call for no new collection of information under the PRA.
Instead, there would likely be a significant reduction in the burden
hours required for information collection 2105-0529, Procedures for
Transportation Drug and Alcohol Testing Program, due to the ability to
use electronic signatures and forms, and largely due to the ability to
use an electronic ATF for DOT-regulated alcohol testing under part 40.
We request comments on this issue. Notwithstanding any other provision
of law, no person shall be subject to any penalty for failing to comply
with a collection of information subject to the PRA that does not
display a currently valid OMB control number.
Privacy Act
Anyone is able to search the electronic form of all comments
received in any of our dockets by the name of the individual submitting
the comment (or signing the comment, if submitted on behalf of an
association, business, labor union, etc.) For information on DOT's
compliance with the Privacy Act, please visit https://www.transportation.gov/privacy.
5 U.S.C. 553(b)(4)
As required by 5 U.S.C. 553(b)(4), a summary of this proposed rule
can be found at the entry for RIN 2105-AF01 in the Department's Portion
of the Unified Agenda of Regulatory and Deregulatory Affairs, available
at https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202404&RIN=2105-AF01.
Pay-As-You-Go Act of 2023
In accordance with Compliance with Pay-As-You-Go Act of 2023
(Fiscal Responsibility Act of 2023, Pub. L. 118-5, div. B, title III)
and OMB Memorandum (M-23-21) dated September 1, 2023, the Department
has determined that this proposed rule is not subject to the Pay-As-
You-Go Act of 2023 because it will not increase direct spending beyond
specified thresholds.
List of Subjects
49 CFR Part 40
Administrative practice and procedures, Alcohol abuse, Alcohol
testing, Drug abuse, Drug testing, Laboratories, Reporting and
recordkeeping requirements, Safety, Transportation.
49 CFR Part 199
Alcohol testing, Drug testing, Pipeline safety, Reporting and
recordkeeping requirements, Safety, Transportation.
For the reasons stated in the preamble, the Department proposes to
amend 49 CFR parts 40 and 199 as follows:
PART 40--PROCEDURES FOR TRANSPORTATION WORKPLACE DRUG AND ALCOHOL
TESTING PROGRAMS
0
1. The authority for part 40 continues to read as follows:
Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and
54101 et seq.
0
2. In Sec. 40.3, add the definitions of ``Electronic signature'' and
``Written or in writing'' in alphabetical order to read as follows:
Sec. 40.3 What do the terms used in this part mean?
* * * * *
Electronic signature. A method of signing an electronic
communication that identifies and authenticates a particular person as
the source of the electronic communication and indicates such person's
approval of the information contained in the electronic communication,
in accordance with the Government Paperwork Elimination Act (Pub. L.
105-277, title XVII, secs. 1701-1710, 112 Stat. 2681-749, 44 U.S.C.
3504 note).
* * * * *
Written or in writing. Printed, handwritten, or typewritten either
on paper or other tangible medium, or by any method of electronic
documentation that meets the requirements of Sec. 40.4.
0
3. Add Sec. 40.4 to read as follows:
Sec. 40.4 May electronic documents and signatures be used?
(a) Applicability. This section applies to all documents required
by this part, except for the CCF. An electronic CCF may be used only if
it has been approved for use by the Department of Health and Human
Services and is used in compliance with Sec. 40.40(c)(5).
(b) Electronic records or documents. Any person or entity required
to
[[Page 82966]]
generate, maintain, or exchange and/or transmit documents to satisfy
requirements in this part may use electronic methods to satisfy those
requirements.
(c) Electronic signatures. (1) Any person or entity required to
sign or certify a document to satisfy the requirements of this part may
use an electronic signature, as defined in Sec. 40.3.
(2) Any available technology may be used that satisfies the
requirements of an electronic signature as defined in Sec. 40.3.
(d) Electronic document requirements. Any person or entity may use
documents signed, certified, generated, maintained, or exchanged using
electronic methods, as long as the documents accurately reflect the
information otherwise required to be contained in them.
(1) Records, documents, or signatures generated, maintained, or
exchanged using electronic methods satisfy the requirements of this
section if they are capable of being retained, are used for the purpose
for which they were created, and can be accurately reproduced within
required timeframes for reference by any party entitled to access.
(2) Records or documents generated electronically satisfy the
requirements of this section if they include proof of consent to use
electronically generated records or documents, as required by 15 U.S.C.
7001(c).
(e) Confidentiality and security. When using electronic documents
and signatures, adequate confidentiality and security measures must be
established 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 to include
protecting against destruction, deterioration, and data corruption.
0
4. In Sec. 40.25, revise paragraph (g) to read as follows:
Sec. 40.25 Must an employer check on the drug and alcohol testing
record of employees it is intending to use to perform safety-sensitive
duties?
* * * * *
(g) The release of information under this section must be in any
written form that ensures confidentiality. As the previous employer,
you must maintain a written record of the information released,
including the date, the party to whom it was released, and a summary of
the information provided.
* * * * *
0
5. In Sec. 40.79, revise paragraph (a)(9) to read as follows:
Sec. 40.79 How is the collection process completed?
(a) * * *
(9) Send Copy 2 of the CCF to the MRO and Copy 4 to the DER. You
must transmit these copies to the MRO and DER within 24 hours or during
the next business day. Keep Copy 3 for at least 30 days, unless
otherwise specified by applicable DOT agency regulations.
* * * * *
0
6. In Sec. 40.97, revise paragraphs (c) introductory text, (c)(1)
introductory text, and (c)(2) to read as follows:
Sec. 40. 97 What do laboratories report and how do they report it?
* * * * *
(c) As a laboratory, you must report laboratory results directly,
and only, to the MRO at his or her place of business. You must not
report results to or through the DER or a service agent (e.g., C/TPA).
(1) Negative results. You must transmit a legible image or copy of
the fully-completed Copy 1 of the CCF which has been signed by the
certifying scientist, or you may provide the laboratory results report
electronically.
* * * * *
(2) Non-negative and rejected for testing results. You must
transmit a legible image or copy of the fully-completed Copy 1 of the
CCF that has been signed by the certifying scientist. In addition, you
may provide the laboratory results report following the format and
procedures set forth in paragraphs (c)(1)(i) and (ii) of this section.
* * * * *
0
7. In Sec. 40.111, revise the section heading and paragraph (b) to
read as follows:
Sec. 40.111 When must a laboratory disclose statistical summaries
and other information it maintains?
* * * * *
(b) When the employer requests a summary in response to an
inspection, audit, or review by a DOT agency, you must provide it
unless the employer had fewer than five aggregate test results. In that
case, you must send the employer a report indicating that not enough
testing was conducted to warrant a summary.
* * * * *
0
8. In Sec. 40.127, revise paragraph (c)(2) to read as follows:
Sec. 40.127 What are the MRO's functions in reviewing negative test
results?
* * * * *
(c) * * *
(2) A legible copy of Copy 1 of the CCF or the electronic
laboratory results report that conveys the negative laboratory test
result.
* * * * *
0
9. In Sec. 40.129, revise paragraphs (b) introductory text and (b)(2)
to read as follows:
Sec. 40.129 What are the MRO's functions in reviewing laboratory
confirmed non-negative drug test results?
* * * * *
(b) Before you report a verified negative, positive, test
cancelled, refusal to test because of adulteration or substitution, you
must have in your possession the following documents:
* * * * *
(2) A legible copy of Copy 1 of the CCF, containing the certifying
scientist's signature.
* * * * *
0
10. In Sec. 40.163, revise paragraphs (c) introductory text and (e) to
read as follows:
Sec. 40.163 How does the MRO report drug test results?
* * * * *
(c) If you do not report test results using Copy 2 of the CCF for
the purposes of this section, you must provide a written report for
each test result. This report must, as a minimum, include the following
information:
* * * * *
(e) You must retain a signed or stamped and dated copy of Copy 2 of
the CCF in your records. If you do not use Copy 2 for reporting
results, you must maintain a copy of the signed or stamped and dated
written report in addition to the signed or stamped and dated Copy 2.
If you use the electronic data file to report negatives, you must
maintain a retrievable copy of that report in a format suitable for
inspection and auditing by a DOT representative.
* * * * *
0
11. In Sec. 40.167, revise paragraph (c)(1) to read as follows:
Sec. 40.167 How are MRO reports of drug test results transmitted to
the employer?
* * * * *
(c) * * *
(1) You must transmit a legible image or copy of either the signed
or stamped and dated Copy 2 or the written report (see Sec. 40.163(b)
and (c)).
* * * * *
0
12. In Sec. 40.185, revise the section heading and paragraph (b) to
read as follows:
[[Page 82967]]
Sec. 40.185 What and to whom must a laboratory report split specimen
results?
* * * * *
(b) You must transmit a legible image or copy of the fully-
completed Copy 1 of the CCF, which has been signed by the certifying
scientist.
* * * * *
0
13. In Sec. 40.187, revise paragraph (c)(2)(iv)(C) to read as follows:
Sec. 40.187 What does the MRO do with split specimen laboratory
results?
* * * * *
(c) * * *
(2) * * *
(iv) * * *
(C) As the laboratory that tests the primary specimen to reconfirm
the presence of the adulterant found in the split specimen and/or to
determine that the primary specimen meets appropriate substitution
criteria, report your result to the MRO using a copy of Copy 1 of the
CCF.
* * * * *
0
14. In Sec. 40.191, revise paragraph (d) introductory text to read as
follows:
Sec. 40.191 What is a refusal to take a DOT drug test, and what are
the consequences?
* * * * *
(d) As a collector or an MRO, when an employee refuses to
participate in the part of the testing process in which you are
involved, you must terminate the portion of the testing process in
which you are involved, document the refusal on the CCF (including, in
the case of the collector, printing the employee's name on Copy 2 of
the CCF), immediately notify the DER by any means that ensures that the
refusal notification is immediately received. As a referral physician
(e.g., physician evaluating a ``shy bladder'' condition or a claim of a
legitimate medical explanation in a validity testing situation), you
must notify the MRO, who in turn will notify the DER.
* * * * *
0
15. In Sec. 40.193, revise paragraph (b)(3) to read as follows:
Sec. 40.193 What happens when an employee does not provide a
sufficient amount of specimen for a drug test?
* * * * *
(b) * * *
(3) As the collector, you must send Copy 2 of the CCF to the MRO
and Copy 4 to the DER. You must transmit these copies to the MRO and
DER within 24 hours or the next business day.
* * * * *
0
16. In Sec. 40.205, revise paragraphs (b)(1) and (2) to read as
follows:
Sec. 40.205 How are drug test problems corrected?
* * * * *
(b) * * *
(1) If the problem resulted from the omission of required
information, you must, as the person responsible for providing that
information, supply in writing the missing information and a statement
that it is true and accurate. For example, suppose you are a collector,
and you forgot to make a notation on the ``Remarks'' line of the CCF
that the employee did not sign the certification. You would, when the
problem is called to your attention, supply a signed statement that the
employee failed or refused to sign the certification and that your
statement is true and accurate. You must supply this information on the
same business day on which you are notified of the problem.
(2) If the problem is the use of a non-Federal form or an expired
Federal form, you must provide a signed statement (i.e., a memorandum
for the record). It must state that the incorrect form contains all the
information needed for a valid DOT drug test, and that the incorrect
form was used inadvertently or as the only means of conducting a test,
in circumstances beyond your control. The statement must also list the
steps you have taken to prevent future use of non-Federal forms or
expired Federal forms for DOT tests. For this flaw to be corrected, the
test of the specimen must have occurred at an HHS-certified laboratory
where it was tested consistent with the requirements of this part. You
must supply this information on the same business day on which you are
notified of the problem.
* * * * *
0
17. In Sec. 40.225, revise paragraph (a) and add paragraphs (d) and
(e) to read as follows:
Sec. 40.225 What form is used for an alcohol test?
(a) The DOT Alcohol Testing Form (ATF) must be used for every DOT
alcohol test. The ATF must be a three-part carbonless manifold form or
an electronic ATF that meets the requirements of paragraph (d) of this
section. The ATF is found in appendix G to this part. You may view this
form on the ODAPC website (https://www.transportation.gov/odapc).
* * * * *
(d) As an employer, you may use an electronic ATF that meets the
following requirements:
(1) The electronic ATF must be identical in form and content to the
ATF found in appendix G to this part.
(2) The electronic ATF must meet the requirements of Sec. 40.4(d).
(3) The electronic ATF must be capable of capturing the electronic
signatures of the employee and the BAT and/or STT.
(4) If an EBT provides a separate printout of confirmation test
results (see Sec. 40.253(g)), the electronic ATF must include that
separate printout.
(e) As an employer, BAT, or STT using an electronic ATF, 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.
0
18. In Sec. 40.255, revise paragraph (a)(5)(i) to read as follows:
Sec. 40.255 What happens next after the alcohol confirmation test
result?
(a) * * *
(5) * * *
(i) You may transmit the results using Copy 1 of the ATF, in
person, by telephone, or by electronic means. In any case, you must
immediately notify the DER of any result of 0.02 or greater by any
means that ensures the result is immediately received by the DER. You
must not transmit these results through C/TPAs or other service agents.
* * * * *
0
19. In Sec. 40.261, revise paragraph (c)(1) to read as follows:
Sec. 40.261 What is a refusal to take an alcohol test, and what are
the consequences?
* * * * *
(c)(1) As a BAT or an STT, or as the physician evaluating a ``shy
lung'' situation, when an employee refuses to test as provided in
paragraph (a) of this section, you must terminate the portion of the
testing process in which you are involved, document the refusal on the
ATF (or in a separate document which you cause to be attached to the
form), immediately notify the DER by any means that ensures the refusal
notification is immediately received. You must make this notification
directly to the DER (not using a C/TPA as an intermediary).
* * * * *
0
20. In Sec. 40.271, revise paragraph (b)(2) to read as follows:
Sec. 40.271 How are alcohol testing problems corrected?
* * * * *
(b) * * *
(2) If the problem is the use of a non-DOT form, you must, as the
person
[[Page 82968]]
responsible for the use of the incorrect form, certify in writing that
the incorrect form contains all the information needed for a valid DOT
alcohol test. You must also provide a signed statement that the
incorrect form was used inadvertently or as the only means of
conducting a test, in circumstances beyond your control, and the steps
you have taken to prevent future use of non-DOT forms for DOT tests.
You must supply this information on the same business day on which you
are notified of the problem.
* * * * *
0
21. In Sec. 40.365, revise paragraphs (b)(13) and (14) and add
paragraph (b)(15) to read as follows:
Sec. 40.365 What is the Department's policy concerning starting a
PIE proceeding?
* * * * *
(b) * * *
(13) For any service agent, directing or recommending that an
employer fail or refuse to implement any provision of this part;
(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); or
(15) For a service agent, failing to provide or maintain a secure/
confidential electronic system.
PART 199--DRUG AND ALCOHOL TESTING
0
22. The authority citation for part 199 continues to read as follows:
Authority: 49 U.S.C. 5103, 60102, 60104, 60108, 60117, and
60118; 49 CFR 1.53.
0
23. In Sec. 199.3:
0
a. Designate the introductory text as paragraph (b); and
0
b. Add paragraph (a).
The addition reads as follows:
Sec. 199.3 Definitions.
(a) Terms used in this part have the same meaning as in 49 CFR
40.3.
* * * * *
0
24. Add Sec. 199.4 to read as follows:
Sec. 199.4 Electronic documents, records, and signatures.
Electronic documents, records, and signatures may be used to comply
with this part provided they meet the requirements specified in 49 CFR
part 40.
0
25. In Sec. 199.117, revise paragraph (a) introductory text to read as
follows:
Sec. 199.117 Recordkeeping.
(a) Each operator shall keep the records in paragraphs (a)(1)
through (5) of this section for the periods specified by this section
or for the periods specified by 49 CFR part 40, whichever is greater;
and will permit access to the records as provided by Sec. 190.203.
* * * * *
0
26. In Sec. 199.119, revise paragraph (a) to read as follows:
Sec. 199.119 Reporting of anti-drug testing results.
(a) Each large operator (having more than 50 covered employees)
must submit an annual Management Information System (MIS) report to
PHMSA of its anti-drug testing using the MIS form and instructions as
required by 49 CFR part 40 (at Sec. 40.26 and appendix J to part 40),
not later than March 15 of each year for the prior calendar year
(January 1 through December 31). The Administrator may require by
notice in the PHMSA Portal (https://portal.phmsa.dot.gov/phmsaportallanding) that small operators (50 or fewer covered
employees), not otherwise required to submit annual MIS reports, to
prepare and submit such reports to PHMSA.
* * * * *
0
27. In Sec. 199.227, revise paragraph (b) introductory text to read as
follows:
Sec. 199.227 Retention of records.
* * * * *
(b) Period of retention. Each operator shall maintain the records
in accordance with the following schedule or for the periods specified
by 49 CFR part 40, whichever is greater:
* * * * *
0
28. In Sec. 199.229, revise paragraph (a) to read as follows:
Sec. 199.229 Reporting of alcohol testing results.
(a) Each large operator (having more than 50 covered employees)
must submit an annual MIS report to PHMSA of its alcohol testing
results using the MIS form and instructions as required by 49 CFR part
40 (at Sec. 40.26 and appendix J to part 40), not later than March 15
of each year for the prior calendar year (January 1 through December
31). The Administrator may require by notice in the PHMSA Portal
(https://portal.phmsa.dot.gov/phmsaportallanding) that small operators
(50 or fewer covered employees), not otherwise required to submit
annual MIS reports, to prepare and submit such reports to PHMSA.
* * * * *
Signed on: Thursday, October 3, 2024.
Pete Buttigieg,
Secretary of Transportation.
[FR Doc. 2024-23427 Filed 10-11-24; 8:45 am]
BILLING CODE 4910-9X-P