[Federal Register Volume 87, Number 150 (Friday, August 5, 2022)]
[Proposed Rules]
[Pages 47951-47956]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-16862]


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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

49 CFR Part 40

[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: Advance Notice of Proposed Rulemaking (ANPRM); request for 
public comments.

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SUMMARY: The Department of Transportation (DOT) requests public comment 
on how its regulations for conducting workplace drug and alcohol 
testing for the federally regulated transportation industry could be 
amended to allow electronic signatures on documents required to be 
created and utilized under the regulations, to be able to use 
electronic versions of forms, and to electronically store 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 part 40 be 
amended to allow the use of an electronic version of the alcohol 
testing form (ATF) for DOT-authorized alcohol testing. The information 
received in response to this ANPRM will assist DOT in the development 
of proposed regulatory amendments intended to provide additional 
flexibility and reduced costs for the industry while maintaining the 
integrity and confidentiality requirements of the drug and alcohol 
testing regulations.

DATES: Comments on this notice must be received on or before October 4, 
2022.

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 ANPRM is organized as follows:

I. Public Participation and Request for Comments
    A. Submitting Comments
    B. Viewing Comments and Documents
    C. Privacy Act
II. Legal Basis for the Rulemaking
III. Purpose of Rulemaking
IV. Adoption of an Electronic CCF
V. General Comments and Questions
VI. Specific Sections of Part 40 that would be Affected
    A. Employee Drug and Alcohol Testing Record
    B. Medical Review Officer (MRO) reporting of verified results
    C. Substance Abuse Professional (SAP) reports
    D. Electronic Alcohol Testing Form (electronic ATF)

I. Public Participation and Request for Comments

A. Submitting Comments

    If you submit a comment, please include the docket number for this 
ANPRM (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. 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 ANPRM, 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 and may initiate a proposed rule based on the comments 
received.

B. Viewing Comments and Documents

    To view comments, as well as any documents mentioned in this 
preamble as being 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.''

[[Page 47952]]

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 
www.transportation.gov/privacy.

II. Legal Basis for the Rulemaking

    This rulemaking is promulgated under the authority enacted in the 
Omnibus Transportation Employee Testing Act (OTETA) of 1991 (Pub. L. 
102-143, tit. V, 105 Stat. 952) and codified at 49 U.S.C. 45102 
(aviation industry testing), 49 U.S.C. 20140 (rail), 49 U.S.C. 31306 
(motor carrier), and 49 U.S.C. 5331 (public transportation).
    The Secretary of Transportation is required by law 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).\1\ The deadline for this action is 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). The deadline for 
DOT's regulatory amendments would therefore be February 28, 2025. DOT 
is issuing this ANPRM now to facilitate the timely proposal and 
adoption of the necessary amendments to part 40 to meet the statutory 
deadline.
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    \1\ This provision was enacted as Section 8108 of the Fighting 
Opioids in Transportation Act of 2018, part of the SUPPORT for 
Patients and Communities Act, Public Law 115-271.
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    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,\2\ 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: (a) for the option of maintaining, 
submitting; or disclosing information electronically, when practicable; 
and (b) for the use and acceptance of electronic signatures when 
practicable. The GPEA states that electronic records and electronic 
signatures shall not be denied legal effect, validity or enforceability 
merely because they are in electronic form. Id.
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    \2\ 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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    The Electronic Signatures in Global and National Commerce Act (E-
SIGN), codified at 15 U.S.C. 7001-7031,\3\ 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 
such 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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    \3\ Public Law 106-229, 114 Stat. 464, enacted on June 30, 2000.
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    In addition to these Federal statutes, the Uniform Electronic 
Transactions Act (UETA) is a uniform state law that was finalized by 
the National Conference of Commissioners on Uniform State Laws in 1999, 
and that has been adopted by 48 States, the District of Columbia, 
Puerto Rico, and the U.S. Virgin Islands.\4\ It provides States a 
framework for determining the legality of an electronic signature in 
both commercial and government transactions.
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    \4\ Illinois and New York have not adopted the UTEA, however 
similar legislation that governs how electronic transactions are 
handled have been enacted in those States.
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III. Purpose of Rulemaking

    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 sought ways to 
reduce the paper documentation associated with the drug and alcohol 
testing program without compromising the integrity and confidentiality 
requirements of the program. In 2000, we permitted greater use of faxed 
and scanned computer images for reporting test results. We also 
permitted laboratories to send electronic reports to MROs.
    From June of 2002 through March of 2003, the Department's Office of 
Drug and Alcohol Policy and Compliance (ODAPC) established the 
Electronic Transmission and Storage of Drug Testing Information Federal 
Advisory Committee, in accordance with the Federal Advisory Committee 
Act (FACA).\5\ The purpose of the Committee was to ``recommend to the 
Department the type and level of electronic security that should be 
used for the transmission and storage of drug testing information 
generated [under part 40]. . . Additionally, the Committee may examine 
and provide advice to the DOT related to the format and methodology 
used in transmitting this type of information as well as the levels and 
procedures to use in implementing electronic signature technology 
within the context of the drug and alcohol program.'' (67 FR 12077; 
March 18, 2002). The participants included representatives from the 
transportation industries, trade associations, labor unions, consortia/
third party administrators (C/TPAs), laboratories certified by the 
Department of Health and Human Services, MROs, and private computer 
companies. The group held three open-session public meetings.
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    \5\ To view the documents associated with the Electronic 
Transmission and Storage of Drug Testing Information Federal 
Advisory Committee, go to https://www.regulations.gov/docket/DOT-OST-2002-12148.
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    Also in 2003, we standardized the format for employers to report 
their Management Information System (MIS) aggregate drug and alcohol 
testing data, as well as the specific data collected. Before that time, 
each DOT Agency required different data in a different format. When 
creating a ONE-DOT MIS Form, we then authorized employers to submit the 
form via a web portal.

[[Page 47953]]

    In 2015, we issued a final rule to allow employers, collectors, 
laboratories, and MROs to use the electronic version of the Federal 
Drug Testing CCF in the DOT-regulated drug testing program. 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. We also included language regarding protecting the physical 
security of records, access controls, and computer security measures to 
safeguard confidential data in electronic form.
    Consistent with the statutory mandate in 49 U.S.C. 322 note, we are 
now considering additional amendments to part 40 to permit the use of 
electronic signatures, forms, and records storage for drug and alcohol 
testing records throughout the regulations (e.g., drug and alcohol 
background checks, MRO reporting of verified results, SAP reports, 
electronic ATF), while at the same time continuing to allow paper, or 
hard-copy use with traditional ''wet signatures.'' These amendments 
would establish parity between paper and electronic collection and 
submission of information required under our regulations (and in 
keeping with applicable OMB regulations) by allowing further use of 
electronic means and methods to comply with part 40 requirements. We 
believe that 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 ensure 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.
    Electronic documents will have a high degree of forensic 
defensibility as long as any changes that are made to the document are 
in the document's electronic footprint, which shows when changes were 
made, and who made them. The use of electronic forms and signatures in 
part 40 will help DOT-regulated employers and their service agents 
improve their workflow efficiency through faster turnaround times for 
required documents. Cost savings will result through reduced printing 
and delivery/shipping costs. We believe this will 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.

IV. Adoption of an Electronic CCF

    As stated earlier in this notice, we have continually sought ways 
to reduce the paperwork burden associated with drug and alcohol testing 
without compromising the integrity and confidentiality requirements of 
the program.
    Initially, the CCF was only available for use in paper form. In 
accordance with GPEA, and in an effort to reduce the Paperwork 
Reduction Act (PRA) burden, HHS authorized the use of an electronic CCF 
for Federal workplace drug testing programs. As with the paper CCF, HHS 
established standards and oversight procedures to ensure the 
authenticity, integrity, and confidentiality of drug test information 
when a Federal electronic CCF is used. On May 28, 2014, the Office of 
Management and Budget (OMB) approved the use of both a paper form CCF 
and an electronic CCF under the HHS Mandatory Guidelines. To permit the 
use of an electronic CCF in the DOT drug testing program, the DOT's 
April 13, 2015, final rule expanded the definition of the CCF in part 
40 to include the electronic CCF. (80 FR 19551). The final rule did not 
require entities to use an electronic CCF--rather, it authorized 
employers to utilize electronic CCFs if the laboratory they use was 
approved by HHS for an electronic CCF. Thus, the ODAPC final rule 
presented another means of compliance for all entities, as permitted 
under the HHS mandatory guidelines.
    Similarly, we do not envision publishing a proposed rulemaking to 
require the use of electronic means for signatures, records, and record 
retention. Instead, we anticipate proposing to allow employers to use 
electronic means for signatures, records, record retention, and other 
purposes within the DOT drug testing program, and an employer could 
choose not to utilize electronic means in any or all of the available 
categories.
    Implementation of the electronic CCF has improved the efficiency 
and accuracy of documenting the urine specimen collection process. The 
accuracy and legibility of the information recorded on an electronic 
CCF is improved over that provided on the paper CCF, as employers are 
able to preprint information and the testing donor is able to verify 
the personally identifiable information (PII) within this clearly 
printed information. The timeframes for the verifications and reporting 
of results also improved with the electronic transmission of the 
appropriate copies to the parties. Prior to use of an electronic CCF, 
the most common method of transmitting the Federal CCF was via fax, but 
some fax machines were able to generate better quality faxes than 
others, and not all collection facilities had fax machines. As a 
result, Federal CCF copies had to be mailed, increasing the timeframes 
for the testing verification and the reporting of results to employers. 
The paper-based process also increased the risk of lost or illegible 
forms.
    Another advantage of the electronic CCF is that the amount of space 
allotted for the collector's ``remarks'' is greatly increased. The 
collector can now enter more descriptive information for the benefit of 
the MRO or employer, and to document any shy bladder collections, 
refusals to test, and other relevant information.
    Just as use of the electronic CCF has improved the efficiency and 
accuracy of documenting the urine specimen collection process, we 
expect that allowing the use of electronic signatures, records, and 
record retention throughout the entirety of part 40 will be a 
significant improvement. We expect advances in workflow efficiency, 
cost savings, and a reduction in longstanding problems associated with 
drug and alcohol testing program documentation and recordkeeping, as 
noted above.

V. General Comments and Questions

    We are initiating this ANPRM to gather 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. We request comments 
and information on appropriate performance standards, and on whether 
particular methods or performance standards have been successful or 
unsuccessful. Additionally, we request comments and information on 
whether to follow industry standards, NIST standards, or something 
else?
    In addition, the ANPRM will allow us to use the information 
gathered to subsequently propose a notice of proposed rulemaking (NPRM) 
that considers current industry standards and practices to the maximum 
extent practicable in developing our own performance standards for 
electronic signatures and records. We anticipate significant cost 
savings for employers and their service agents. We do not want to cause 
an unreasonable increase in costs by requiring inefficient or expensive 
systems. Beginning this

[[Page 47954]]

rulemaking action as an ANPRM will help us to achieve these goals.
    We want to ensure that we put forth viable minimum standards for 
the use of technology, so that the integrity and confidentiality 
requirements of the program can continue to be met. The importance of 
ensuring the confidentiality, integrity, and availability of the data, 
and limiting access to any data transmission, storage, and retrieval 
systems, cannot be overemphasized. Even as we amend part 40 to permit 
the use of electronic methods, we will retain the option for regulated 
entities to use a paper-based system. We recognize that many of our 
program participants, such as small transportation employers, may not 
be equipped to participate in a fully electronic system. Therefore, we 
seek comment on the potential, advantages, risks, ramifications, and 
required safeguards associated with use of electronic forms, 
signatures, and records in the DOT drug and alcohol testing program.
    Given the above, we request information regarding the following 
general questions:
    (1) What are the practical impacts of authorizing a fully or 
partially electronic system?
    (2) What are the economic impacts of authorizing a fully or 
partially electronic system?
    (3) How would confidentiality and system security be maintained to 
prevent against data breach and data loss?
    (4) How many levels of authentication should be utilized to ensure 
the reliability and security of the signatures of program participants?
    (5) How is the non-repudiation \6\ of a system ensured?
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    \6\ In a general information security context, non-repudiation 
is assurance that the sender of information is provided with proof 
of delivery, and the recipient is provided with proof of the 
sender's identity, so neither can later deny having processed the 
information.
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    (6) Are there any lessons learned or shared best practices 
available related to paperless non-DOT regulated testing?
    (7) Are there any limitations in either a paperless or electronic 
environment that impact program efficiency?
    (8) Would moving to a paperless system involve the creation of more 
labels and bar codes and use of additional packaging, etc., not 
required in a paper-based system. If so, are there any cost and/or 
efficiency impacts as a result?
    (9) What additional definitions would need to be added to part 40 
to accommodate any electronic capabilities or a fully electronic 
system?
    (10) What measures need to be established to ensure that, when 
documents are transmitted to multiple parties, each party is able to 
properly access and use the electronic system?
    (11) Part 40 requires urine collectors and breath alcohol 
technicians (BAT) to prepare a memorandum for the record (MFR) when 
certain problems are encountered during the conduct of a drug or 
alcohol test under part 40. How would the MFR be created and 
transmitted to MROs, laboratories, and employers electronically?
    (12) Part 40 requires communication between MROs and the employee's 
physician regarding shy bladder situations, certain safety concerns, 
and opioids evaluations. Could these communications be handled 
electronically? If so, how?
    (13) Should third parties (i.e., IT and security consultants, data 
management firms, etc.) play a role in maintaining electronic systems 
and transmitting data for employers? If so, to what degree?
    (14) If records are kept electronically, and the business 
relationship ends, how would employers ensure that they have access to 
their electronic records if switching recordkeeping services, or if the 
service agent maintaining their electronic records goes out of 
business? Relatedly, how can employers ensure that records are not 
deleted, potentially leaving the DOT program participant without the 
records they are required to maintain under part 40?

VI. Specific Sections of Part 40 That Would Be Affected

A. Employee Drug and Alcohol Testing Record

    DOT regulations at 49 CFR 40.25 establish requirements for 
employers to check on the drug and alcohol testing record of employees 
who the employer intends will perform safety-sensitive duties. This 
section requires an employer, after obtaining an employee's written 
consent, to request certain information regarding the employee's drug 
and alcohol testing history from DOT-regulated employers that have 
employed the employee during any period during a minimum of the 2 years 
before the date of the employee's application or transfer. This section 
also requires the previous employer to maintain a written record of the 
information released, including the date, the party to whom it was 
released, and a summary of the information released. Further, the 
employer requesting the information required under this section must 
maintain a written, confidential record of the information obtained.
    We note that the Federal Motor Carrier Safety Administration 
(FMCSA) published a final rule on December 5, 2016 (81 FR 87686) to 
establish requirements for the Commercial Driver's License Drug and 
Alcohol Clearinghouse (Clearinghouse), a database under the Agency's 
administration that contains information about violations of FMCSA's 
drug and alcohol testing program for the holders of commercial driver's 
licenses (CDLs).\7\ This rule was mandated by 49 U.S.C. 31306a.\8\ The 
Clearinghouse is a secure online database that gives employers, FMCSA, 
State Driver Licensing Agencies, and State law enforcement personnel 
real-time information about CDL driver drug and alcohol program 
violations, thereby enhancing safety on our Nation's roadways.
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    \7\ In a final rule dated October 7, 2021, FMCSA expanded the 
scope of the State Driver Licensing Agencies' Clearinghouse query 
requirement to also include drivers that hold Commercial Learner's 
Permits in addition to drivers that hold CDLs (86 FR 55718).
    \8\ This provision was enacted into law in the Moving Ahead for 
Progress in the 21st Century Act (MAP-21), Public Law 112-141, 126 
Stat. 405.
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    Beginning on January 6, 2020, employers were required to conduct 
both electronic queries and traditional manual inquiries with previous 
employers to meet the 3-year timeframe, required by FMCSA's drug and 
alcohol use testing program, for checking CDL driver violation 
histories. Beginning on January 6, 2023, once 3 years of violation data 
are stored in the Clearinghouse, FMCSA-regulated employers must conduct 
a pre-employment query of the Clearinghouse to comply with the 
requirements in 49 CFR 40.25 and 49 CFR 391.23(e) with respect to 
FMCSA-regulated employers. An FMCSA-regulated employer must continue to 
directly request information from the driver's previous employers 
regulated by a DOT agency other than FMCSA.
    We seek information regarding how the requirements in Sec.  40.25, 
along with record keeping requirements, can be satisfied for employers 
who are not required to enter data into the FMCSA's Clearinghouse. If 
part 40 is amended to authorize the use of electronic forms, 
signatures, and record retention, how can DOT structure regulatory 
provisions to protect an employee's personal information and related 
drug test information?

B. MRO Reporting of Verified Results

    DOT regulations at 49 CFR 40.163 require MROs to report all drug 
test results to the employer using either (1)

[[Page 47955]]

a signed or stamped and dated legible photocopy of Copy 2 of the CCF, 
or (2) a written report that must include, at a minimum, the 
information listed in Sec.  40.163(c)(1)-(9) (which includes much of 
the information provided on Copy 2 of the CCF).\9\ This section also 
requires MROs to maintain reports and records related to negatives and 
cancelled results for one year, and records and reports related to 
positives and refusals for five years, unless otherwise specified by 
applicable DOT agency regulations.
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    \9\ As an exception to the reporting requirements listed, the 
regulation permits an MRO to report negative results using an 
electronic data file provided that the report includes, at a 
minimum, (1) the information specified in Sec.  40.163(c)(1)-(9), 
and (2) the MRO's name, address, and phone number, the name of any 
other person reporting the results, and the date the electronic 
results report is released.
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    In addition, Sec.  40.167 requires MROs or C/TPAs to transmit the 
MRO's report(s) of verified tests to the designated employer 
representative (DER) so that the DER receives the report within 2 days 
of verification by the MRO. The MRO or C/TPA must fax, courier, mail, 
or electronically transmit a legible image or copy of either the signed 
or stamped and dated Copy 2 of the CCF or the written report as 
required by Sec.  40.163. In transmitting the test results, the MRO or 
the C/TPA and the employer must ensure the security of the transmission 
and limit access to any transmission, storage, or retrieval systems.
    We seek information regarding how the requirements in Sec. Sec.  
40.163 and 40.167 can be satisfied if part 40 is amended to authorize 
the use of electronic forms, signatures, and record retention.
    We also seek information on how MROs, C/TPAs, and employers 
currently ensure the security of the transmission and limit access to 
any transmission, storage, or retrieval systems when transmitting test 
results. Would additional requirements be needed in any amendments to 
part 40?
    We recognize that many occupational medical practices, hospitals 
and other medical groups conduct collections, perform MRO and C/TPA 
functions, along with their medical practices. However, the DOT drug 
and alcohol testing records of donors must not be combined with systems 
with patient medical records because only those persons with a need to 
know about the DOT drug and alcohol testing programs can have access to 
the records. Would additional requirements be needed to ensure that 
separate systems are maintained?

C. SAP Reports

    DOT regulations at 49 CFR 40.311 require SAPs to provide written 
reports, directly to a DER, following the SAP's (1) initial evaluation 
that determines what level of assistance is needed to address the 
employee's drug and/or alcohol problems, and (2) follow-on evaluation 
that determines whether the employee has or has not demonstrated 
successful compliance with the conditions outlined as a result of the 
initial evaluation. This section requires that these written reports be 
on the SAP's own letterhead (and not the letterhead of another service 
agent), be signed and dated by the SAP, and contain the information 
contained in Sec.  40.311(c)-(e) as appropriate. SAPs are required to 
maintain copies of reports to employers for 5 years, and must maintain 
employee clinical records in accordance with Federal, state, and local 
laws regarding record maintenance, confidentiality, and release of 
information.
    We seek information regarding how the requirements in Sec.  40.311 
can be satisfied if part 40 is amended to authorize the use of 
electronic forms, signatures, and record retention. As with all other 
information relating to drug and alcohol testing and results, how can 
the confidentiality of information be protected? What provisions are 
needed to ensure that the SAP reports are transmitted only to the DER?

D. Electronic Alcohol Testing Form (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 for every 
DOT alcohol test. DOT regulations at 49 CFR 40.225 set forth the 
implementing regulations, 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 
Screening Test Technician (STT) and/or a BAT will complete the ATF in 
various sections. The BAT/STT documents the result(s) by either writing 
in the screening result or attaching the screening and/or confirmation 
result printed by the 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 submitted a petition for rulemaking to DOT 
requesting that part 40 be amended to allow for the use of an 
electronic version of the ATF for DOT-mandated alcohol testing. In its 
petition, DISA states that it has worked collaboratively with software 
companies and evidential breath testing device manufacturers over the 
past five years in developing and deploying the use of an electronic 
alcohol testing form for documentation of alcohol testing conducted 
under employers' policy authority. DISA believes that its benefits are 
applicable and appropriate to DOT-mandated alcohol testing of safety-
sensitive employees. DISA contends that use of an electronic ATF will 
result in (1) an increase in the efficiency, security, and accuracy in 
documenting DOT alcohol tests, (2) a reduction in paperwork, (3) an 
improved process for conducting a DOT alcohol test in conjunction with 
a DOT drug test when an electronic CCF is used for the drug test, (4) a 
reduction of errors and omissions in the completion of the ATF, (5) an 
improvement in the efficiency and efficacy in the transmission and 
record retention of alcohol test results, and (6) a substantial cost 
savings by eliminating the requirement for the printing and 
distribution of carbonless three-ply paper ATFs.
    We agree that employers and MROs have seen the benefits of using 
the electronic CCF (e.g., legible information on all copies, reduced 
collector error, expedited reporting), and the corresponding 
improvements and efficiencies in the DOT drug testing program. Given 
these benefits, along with the DISA petition for rulemaking and the 
statutory mandate, we believe that it is feasible, and preferable, to 
align the DOT drug and alcohol testing programs by enabling the use of 
an electronic ATF. It should be noted that in requesting comments on 
the implementation of an electronic ATF in the DOT alcohol testing 
program, we are not seeking comments on changes to (1) the existing 
alcohol testing procedures, (2) the existing alcohol testing device 
specifications, or (3) the content of the current approved ATF.
    Similar to the steps taken in HHS's establishment and adoption of 
the electronic CCF, we must consider the necessary components and 
processes associated with an electronic ATF, including the associated 
procedures and systems that would need to be developed and maintained 
to appropriately safeguard stored information. Additionally, and 
similar to what was done in establishing the electronic CCF, we would 
not contemplate making use of the electronic ATF mandatory, nor would 
we seek to make any revisions to the

[[Page 47956]]

information collected on the existing alcohol testing form.
    In considering the factors involved with providing for an 
electronic ATF in the alcohol testing program regulations, we seek 
specific information from affected entities and other interested 
parties about any impact the potential use of an electronic ATF might 
have.
    Even though use of the electronic ATF (like the electronic CCF) 
would be voluntary, we are interested in discerning the cost impact and 
any and all factors that would need to be considered to enable use of 
an electronic ATF including, but not limited to: (1) necessary 
documentation and procedures needed to establish the electronic ATF; 
(2) necessary system components (hardware and software requirements); 
(3) compatibility of the form and associated systems between alcohol 
testing program participants (such as between an STT and a BAT and 
employer); (4) training considerations; (5) system maintenance; (6) 
system security (protection of an employee's personal information and 
related test result); and (7) and archival and audit trail 
considerations.

Conclusion

    With this ANPRM, the Department seeks input on the questions set 
forth above. We welcome comments on all aspects of the ANPRM, and all 
interested parties are encouraged to provide their views.

Delegation

    This ANPRM is issued through authority delegated to the General 
Counsel through a memorandum that has been placed in the docket for the 
rulemaking action. (See https://www.regulations.gov/document/DOT-OST-2022-0027-0001.)

John E. Putnam,
General Counsel, U.S. Department of Transportation.
[FR Doc. 2022-16862 Filed 8-4-22; 8:45 am]
BILLING CODE 4910-9X-P


