[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:
    <bullet> Federal eRulemaking Portal: Go to https://www.regulations.gov/docket/DOT-OST-2022-0027/document. Follow the 
online instructions for submitting comments.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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; <a href="/cdn-cgi/l/email-protection#6728232637241002050a060e0b2703081349000811"><span class="__cf_email__" data-cfemail="efa0abaebfac988a8d828e8683af8b809bc1888099">[email protected]</span></a>. 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.
---------------------------------------------------------------------------

    \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


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