Proposed Rule2022-16862
Electronic Signatures, Forms and Storage for Drug and Alcohol Testing Records
Primary source
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Published
August 5, 2022
Issuing agencies
Transportation Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 150 (Friday, August 5, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<bullet> Federal eRulemaking Portal: Go to <a href="https://www.regulations.gov/docket/DOT-OST-2022-0027/document">https://www.regulations.gov/docket/DOT-OST-2022-0027/document</a>. 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#7639323726350113141b171f1a3612190258111900"><span class="__cf_email__" data-cfemail="59161d18091a2e3c3b34383035193d362d773e362f">[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 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 <a href="https://www.regulations.gov/docket/DOT-OST-2022-0027/document">https://www.regulations.gov/docket/DOT-OST-2022-0027/document</a>, 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="http://www.regulations.gov">www.regulations.gov</a>, as described in the system
of records notice (DOT/ALL-14 FDMS), which can be reviewed at
<a href="http://www.transportation.gov/privacy">www.transportation.gov/privacy</a>.
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 <a href="https://www.regulations.gov/docket/DOT-OST-2002-12148">https://www.regulations.gov/docket/DOT-OST-2002-12148</a>.
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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 <a href="https://www.regulations.gov/document/DOT-OST-2022-0027-0001">https://www.regulations.gov/document/DOT-OST-2022-0027-0001</a>.)
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
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