Treatment of E-Cigarettes in the Mail, 10218-10220 [2021-03393]
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10218
Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Proposed Rules
tkelley on DSKBCP9HB2PROD with PROPOSALS
government overseeing a population
below 50,000.
The small entities that this proposed
regulatory action would affect are public
or private nonprofit agencies and
organizations, including Indian Tribes
and institutions of higher education,
that may apply. We believe that the
costs imposed on an applicant by the
proposed priority would be limited to
paperwork burden related to preparing
an application and that the benefits of
this proposed priority would outweigh
any costs incurred by the applicant.
There are very few entities who could
provide the type of training and
technical assistance required under the
proposed priority. For these reasons, the
proposed priority would not impose a
burden on a significant number of small
entities.
Paperwork Reduction Act of 1995:
The proposed priority contains
information collection requirements that
are approved by OMB under OMB
control number 1820–0018.
Intergovernmental Review: This
program is subject to Executive Order
12372 and the regulations in 34 CFR
part 385. One of the objectives of the
Executive order is to foster an
intergovernmental partnership and a
strengthened federalism. The Executive
order relies on processes developed by
State and local governments for
coordination and review of proposed
Federal financial assistance.
This document provides early
notification of our specific plans and
actions for this program.
Assessment of Educational Impact
In accordance with section 411 of the
General Education Provisions Act, 20
U.S.C. 1221e–4, the Secretary
particularly requests comments on
whether these proposed regulations
would require transmission of
information that any other agency or
authority of the United States gathers or
makes available.
Accessible Format: On request to the
program contact person listed under FOR
FURTHER INFORMATION CONTACT,
individuals with disabilities can obtain
this document and a copy of the
application package in an accessible
format. The Department will provide the
requestor with an accessible format that
may include Rich Text Format (RTF) or
text format (txt), a thumb drive, an MP3
file, braille, large print, audiotape, or
compact disc, or other accessible format.
Electronic Access to This Document:
The official version of this document is
the document published in the Federal
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edition of the Federal Register and the
Code of Federal Regulations at
VerDate Sep<11>2014
18:27 Feb 18, 2021
Jkt 253001
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David Cantrell,
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Education Programs. Delegated the authority
to perform the functions and duties of the
Assistant Secretary for the Office of Special
Education and Rehabilitative Services.
[FR Doc. 2021–03422 Filed 2–18–21; 8:45 am]
BILLING CODE 4000–01–P
POSTAL SERVICE
39 CFR Part 113
Treatment of E-Cigarettes in the Mail
Postal ServiceTM.
Proposed revision, invitation for
comment.
AGENCY:
ACTION:
The Postal Service proposes
to revise Publication 52, Hazardous,
Restricted, and Perishable Mail, to
incorporate new statutory restrictions
on the mailing of electronic nicotine
delivery systems. Such items would be
subject to the same prohibition as
cigarettes and smokeless tobacco,
subject to many of the same exceptions.
DATE: We must receive your comments
on or before March 22, 2021.
ADDRESSES: Mail or deliver written
comments to the Manager, Product
Classification, U.S. Postal Service, 475
L’Enfant Plaza SW, Room 4446,
Washington, DC 20260–3436. Email
comments, containing the name and
address of the Commenter, may be sent
to: PCFederalRegister@usps.gov, with a
subject line of ‘‘E-Cigarette
Restrictions.’’ Faxed comments are not
accepted. All submitted comments and
attachments are part of the public record
and subject to disclosure. Do not
enclose any material in your comments
that you consider to be confidential or
inappropriate for public disclosure.
You may inspect and photocopy all
written comments, by appointment
only, at USPS® Headquarters Library,
475 L’Enfant Plaza SW, 11th Floor
North, Washington, DC 20260. These
records are available for review Monday
SUMMARY:
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through Friday, 9 a.m. and 4 p.m. by
calling 202–268–2906.
FOR FURTHER INFORMATION CONTACT: Dale
E. Kennedy, 202–268–6592.
SUPPLEMENTARY INFORMATION: The Postal
Service is proposing to amend
Publication 52 with the provisions
described below and, once adopted, will
incorporate the revised Publication 52
by reference into 39 CFR part 113. You
may view the text of the proposed edits
to Publication 52 at https://pe.usps.com.
On December 27, 2020, the Preventing
Online Sales of E-Cigarettes to Children
Act (‘‘Act’’), Public Law 116–160, div.
FF, title VI (2020), was enacted.
Effective 90 days after enactment,
Section 602 of the Act adds ‘‘electronic
nicotine delivery systems’’ (ENDS) to
the definition of ‘‘cigarettes’’ subject to
regulation under the Jenkins Act, 15
U.S.C. 375 et seq. Consequently, ENDS
will also become subject to the
mailability restrictions and exceptions
in 18 U.S.C. 1716E, which rely on the
Jenkins Act definition of ‘‘cigarettes.’’ 18
U.S.C. 1716E(a)(1). Section 603 of the
Act requires the Postal Service to
promulgate implementing regulations
not later than 120 days after enactment
and provides that the prohibition on
mailing ENDS will apply immediately
‘‘on and after’’ the date of the final rule.
Current Mailing Restrictions on
Cigarettes and Smokeless Tobacco
Currently, 18 U.S.C. 1716E bans the
mailing of cigarettes and smokeless
tobacco except in narrowly defined
circumstances, as described below.
• Noncontiguous States: Intrastate
shipments within Alaska or Hawaii;
• Business/Regulatory Purposes:
Shipments transmitted between verified
and authorized tobacco industry
businesses for business purposes, or
between such businesses and federal or
state agencies for regulatory purposes;
• Certain Individuals: Lightweight
shipments mailed between adult
individuals, limited to 10 per 30-day
period;
• Consumer Testing: Limited
shipments of cigarettes sent by verified
and authorized manufacturers to adult
smokers for consumer testing purposes;
and
• Public Health: Limited shipments
by federal agencies for public health
purposes under similar rules applied to
manufacturers conducting consumer
testing.
18 U.S.C. 1716E(b)(2)–(6). Outside of
these exceptions, the Postal Service
cannot accept or transmit any package
that it knows, or has reasonable cause to
believe, contains nonmailable smokeless
tobacco or cigarettes. Id. at (a)(1).
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Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Proposed Rules
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The Postal Service has determined
that the exceptions above cannot
feasibly be applied to inbound or
outbound international mail, mail to or
from the Freely Associated States, or
mail presented at overseas Army Post
Office (APO), Fleet Post Office (FPO), or
Diplomatic Post Office (DPO) locations
and destined to addresses in the United
States. Publication 52, Hazardous,
Restricted and Perishable Mail 472.2. As
such, all cigarettes and smokeless
tobacco in such mail are nonmailable,
without exception.
Nonmailable cigarettes and smokeless
tobacco deposited in the mail are
subject to seizure and forfeiture. 18
U.S.C. 1716E(c). Senders of nonmailable
cigarettes or smokeless tobacco are
subject to criminal fines, imprisonment,
and civil penalties, in addition to
enforcement under other federal, state,
and local laws. Id. at (d), (e), (h).
Definition of ENDS
The proposed rule uses the definition
of ENDS contained in 15 U.S.C. 375(7),
as amended by section 602(a)(1)(C) of
the Act. Under this definition, an ENDS
is any electronic device that, through an
aerosolized solution, delivers nicotine,
flavor, or any other substance to the user
inhaling from the device. Examples
include e-cigarettes, e-hookahs, e-cigars,
vape pens, advanced refillable personal
vaporizers, and electronic pipes.
Provisions relating to ENDS also extend
to any component, liquid, part, or
accessory of an ENDS, regardless of
whether sold separately from the device.
Despite the name, an item can qualify as
an ENDS without regard to whether it
contains or is intended to be used to
deliver nicotine; liquids that do not
actually contain nicotine can still
qualify as ENDS, as can devices, parts,
components, and accessories capable of
or intended for use with non-nicotinecontaining liquids.
Excluded from the statutory definition
are products approved by the Food and
Drug Administration for sale as tobacco
cessation products or for other
therapeutic purposes and marketed and
sold solely for such purposes.
Accordingly, the proposed rule excludes
such items from the definition of ENDS.
Approved tobacco cessation and
therapeutic products thus remain
mailable in domestic mail, international
mail, mail treated as domestic, and mail
from overseas APO/FPO/DPO addresses
to United States destination addresses.
Extension of Existing Provisions to
ENDS in General; Terminology
In general, the proposed rule would
extend the current treatment of
cigarettes and smokeless tobacco to
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ENDS. This is consistent with how the
Act formally includes ENDS within the
definition of ‘‘cigarettes’’ in 15 U.S.C.
375(2)(A)(ii), which is used in 18 U.S.C.
1716E. Consequently, all existing
restrictions on and exceptions for
‘‘cigarettes’’ apply to ENDS, except
where context indicates otherwise.
It is not intuitive that ENDS should be
understood as a form of ‘‘cigarette.’’ In
general parlance, ‘‘cigarettes’’ most
commonly consist of ground leaf
tobacco wrapped in paper, which
deliver nicotine to a smoker when solid
matter is combusted, and the resulting
smoke inhaled. ENDS are electronic
devices and their components and
fillers, which deliver either nicotine or
non-nicotine substances to a user when
a liquid is vaporized, and the resulting
vapor inhaled. To facilitate
understanding by readers not versed in
the statute, we propose to treat ENDS as
a standalone category, albeit one
generally subject to the same restrictions
and exceptions as cigarettes, consistent
with the statute.
We have considered two ways in
which to express this generally
equivalent treatment. First, cigarettes,
ENDS, and smokeless tobacco could be
listed serially in every applicable
instance; however, this option appears
to unduly clutter the rules’ text. Second,
we could employ a shorthand term to
encompass all three types of items.
Indeed, the statute itself appears to take
this approach. Although the term is not
defined in either 18 U.S.C. 1716E or 15
U.S.C. 375, ‘‘tobacco product’’ is used in
the title of 18 U.S.C. 1716E and
throughout its text as apparent
shorthand for the products made
nonmailable by that section (i.e.,
cigarettes and smokeless tobacco).
Because ENDS now fall within that
scope through their inclusion in the
pertinent statutory definition of
‘‘cigarettes,’’ it seems reasonable to use
the umbrella term ‘‘tobacco product’’ to
refer to ENDS as well as cigarettes and
smokeless tobacco. Hence, we propose
to add a definition of ‘‘tobacco
products’’ and to replace numerous
instances of ‘‘cigarettes and smokeless
tobacco’’ with ‘‘tobacco products.’’
This proposed solution admittedly
shares some of the same conceptual
difficulty discussed above in relation to
cigarettes: Technically speaking, ENDS
are not products derived from tobacco.
In this instance, however, the general
conceptual alignment, together with the
benefits of a shorthand term and
consistency with the statute’s use of the
term, appear to weigh in favor of
‘‘tobacco product’’ in reference to all
products nonmailable under 18 U.S.C.
1716E. Commenters are invited to
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10219
propose alternative terminological
approaches and to discuss the relative
merits of their proposals.
Standards for Determining
Nonmailability
Current law requires the Postal
Service to treat shipments of cigarettes
and smokeless tobacco as nonmailable
not only where Postal Service personnel
have actual knowledge that a shipment
contains such items, but also where
Postal Service personnel have
‘‘reasonable cause to believe’’ that such
contents are present. 18 U.S.C.
1716E(a)(1). ‘‘Reasonable cause’’ exists
where a party is on the U.S. Attorney
General’s List of Unregistered or
Noncompliant Delivery Sellers, and
where public statements or
advertisements indicate an intent to
mail nonmailable cigarettes or
smokeless tobacco for payment. Id. at
(a)(2). The statute’s use of ‘‘includes’’
before these enumerations of
‘‘reasonable cause’’ plainly indicates
that the list is illustrative, rather than
exhaustive, but it is silent on what else
constitutes ‘‘reasonable cause.’’ Beyond
those enumerated indicia of suspicion,
other circumstances pertaining to a
mailpiece may give rise to a reasonable
suspicion that a package contains
nonmailable cigarettes, smokeless
tobacco, or ENDS. Where Postal Service
personnel observe such circumstances
and determine that reasonable cause
exists, they may treat a package as
nonmailable. The proposed rule would
make this explicit.
In the specific context of ENDS, the
new statutory definition conditions
mailability on factors that are extrinsic
to the physical item: Namely, whether a
product is FDA-approved for
therapeutic or tobacco-cessation use,
and whether it is marketed and sold
exclusively for such purposes. These
circumstances are known or knowable
by a mailer, but they are not necessarily
apparent to Postal Service personnel
reviewing a package. If the possessor of
an FDA-approved and exclusively
marketed therapeutic or tobaccocessation product wishes to mail it, then
that person has the unique means and
incentive to provide adequate
information with the package so that
Postal Service personnel can identify
the otherwise nonmailable item as, in
fact, mailable. If a mailer does not do so,
then the Postal Service has no basis to
disbelieve indicia indicating the
presence of a nonmailable ENDS.
In expecting the mailer to supply such
information, the Postal Service must be
able to verify that the mailer is acting in
good faith and not illegitimately treating
the therapeutic/tobacco-cessation
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exclusion as an opportunity to evade the
general mailing ban. If the mailer’s
claim to the exclusion is not
appropriately credible or verifiable, then
that claim may not be sufficient to
deprive the Postal Service of reasonable
cause to believe that the item is a
nonmailable ENDS. Therefore, the
proposed rule would authorize Postal
Service personnel, upon reasonable
cause to believe that a package contains
cigarettes, smokeless tobacco, or ENDS,
to treat the package as nonmailable
unless the customer has affirmatively,
credibly, and verifiably indicated that
the relevant contents are, in fact,
mailable.
Commenters are invited to offer their
views on this proposed standard for
reasonable cause in connection with
ENDS-type items (or any other tobacco
products). To the extent that
commenters might propose alternative
standards, commenters are advised to
account specifically for the need to
prevent abuse of the narrow exclusion
of therapeutic and tobacco-cessation
products; the asymmetry between
mailers’ and the Postal Service’s access
to information about the FDA-approval
status and marketing of particular
products; the Postal Service’s limited
resources; and its limited legal authority
to open mailpieces that are sent in
sealed mail classes without a warrant.
39 U.S.C. 404(c); 39 CFR 233.3(c)(3)–(4),
(g)(1)–(2).
Applicability of Exceptions
The existing Noncontiguous States,
Business/Regulatory Purposes, and
Certain Individuals exceptions appear to
be articulated in terms that can apply to
ENDS as well as to cigarettes and
smokeless tobacco. As such, the
proposed use of the umbrella term
‘‘tobacco products’’ in the rules for each
exception would automatically apply all
such existing rules to ENDS.
Commenters are nonetheless invited to
identify any potential anomalies or
other problems that this approach might
create and to recommend solutions for
such problems.
The Consumer Testing and Public
Health exceptions apply only to
‘‘cigarettes,’’ and not to smokeless
tobacco. 18 U.S.C. 1716E(b)(5)–(6). As
noted earlier, the Act technically
includes ENDS within the relevant
definition of ‘‘cigarettes.’’ Without more,
this would ordinarily indicate that these
exceptions should apply to ENDS as
well as other forms of ‘‘cigarettes.’’
However, 18 U.S.C. 1716E(b)(5)(A)(ii) or
(C)(ii)(III) confine the exceptions to
packages containing ‘‘not more than 12
packs of cigarettes (240 cigarettes).’’
Congress did not amend these
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18:27 Feb 18, 2021
Jkt 253001
provisions when it included ENDS,
broadly defined, in the definition of
‘‘cigarettes,’’ and neither the text of the
Act nor its legislative history contains
any guidance as to how these conditions
should apply to ENDS.
ENDS are not packaged in such
standard quantities as traditional
cigarettes. ENDS rely on devices that
can be used in an open-ended fashion,
with potentially limitless quantities of
liquid filled cartridges, whereas
traditional cigarettes are self-contained,
single-use items. Moreover, ENDS filler
liquids can contain varying quantities of
nicotine, or even no nicotine, whereas
cigarettes uniformly contain nicotine.
As such, it does not appear possible
even to devise an administrable
standard of equivalence that would
allow ‘‘12 packs of cigarettes (240
cigarettes)’’ to be translated into some
quantity of ENDS filler liquid, let alone
ENDS products other than filler liquid.
Given the Act’s broad definition of
ENDS and the material differences
between ENDS products and the types
of products originally encompassed by
the Consumer Testing and Public Health
exceptions, it appears reasonable to
construe the lack of accommodation for
ENDS in the relevant statutory text to
render those exceptions inapplicable to
ENDS. To the extent that commenters
believe that the Consumer Testing and
Public Health exceptions should apply
to ENDS, commenters are invited to
recommend alternative standards
consistent with Congress’s apparent
intent to limit the quantity of items
mailed in packages under the
exceptions. Commenters should explain
in detail how any proposed alternative
quantity limits are analogous to or
otherwise consistent with those in 18
U.S.C. 1716E(b)(5)(A)(ii) or (C)(ii)(III), or
why such consistency is not necessary.
Commenters are also invited to furnish
any relevant documentation or
supporting information that may aid the
Postal Service in evaluating their
recommendations.
Effective Date of Eventual Final Rule
Particularities here merit a brief
discussion of the timing of the eventual
final rule, in the interest of providing
stakeholders with advance information.
Section 603(a) of the Act requires the
Postal Service ‘‘promulgate regulations
to clarify the applicability of the
prohibition on mailing of cigarettes’’ to
ENDS not later than 120 days after
enactment (i.e., April 26, 2021). Section
603(b) provides that the prohibition will
apply to mailings of ENDS ‘‘on and
after’’ the publication date of the final
rule. In specifying this immediate
effective date, Congress expressly
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abrogated the standard 30-day notice
period for a final rule under the
Administrative Procedure Act (APA),
which would otherwise apply to
rulemakings concerning the mailability
statute here. 5 U.S.C. 553(d), 559; 39
U.S.C. 3001(m). To the extent that this
rulemaking concerns not only the
mailing prohibition referenced in the
Act, but also the application of
exemptions from that prohibition, the
APA permits those aspects of the
eventual final rule likewise to take effect
with less than 30 days’ notice (e.g.,
immediately upon publication). 5 U.S.C.
553(d)(1).
Joshua J. Hofer,
Attorney, Ethics and Legal Compliance.
[FR Doc. 2021–03393 Filed 2–17–21; 11:15 am]
BILLING CODE 7710–12–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R10–OAR–2019–0599, FRL–10019–
38–Region 10]
Air Plan Approval; OR; Smoke
Management Revision
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
Environmental Protection
Agency (EPA) is proposing to approve
Oregon State Implementation Plan (SIP)
revisions submitted on November 3,
2014 and September 27, 2019. The
submitted revisions incorporate by
reference the most recent updates to
Oregon’s Smoke Management Plan. EPA
is acting only on the most recent version
of such regulations as the previous
versions are no longer in effect as a
matter of state law. EPA is also making
technical corrections related to previous
approvals of components of Oregon’s
SIP. EPA is proposing to determine that
the changes are consistent with Clean
Air Act requirements.
DATES: Comments must be received on
or before March 22, 2021.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R10–
OAR–2019–0599, at https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Once submitted, comments cannot be
edited or removed from https://
www.regulations.gov. EPA may publish
any comment received to its public
docket. Do not electronically submit any
information you consider to be
Confidential Business Information (CBI)
or other information the disclosure of
SUMMARY:
E:\FR\FM\19FEP1.SGM
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Agencies
[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Proposed Rules]
[Pages 10218-10220]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03393]
=======================================================================
-----------------------------------------------------------------------
POSTAL SERVICE
39 CFR Part 113
Treatment of E-Cigarettes in the Mail
AGENCY: Postal ServiceTM.
ACTION: Proposed revision, invitation for comment.
-----------------------------------------------------------------------
SUMMARY: The Postal Service proposes to revise Publication 52,
Hazardous, Restricted, and Perishable Mail, to incorporate new
statutory restrictions on the mailing of electronic nicotine delivery
systems. Such items would be subject to the same prohibition as
cigarettes and smokeless tobacco, subject to many of the same
exceptions.
DATE: We must receive your comments on or before March 22, 2021.
ADDRESSES: Mail or deliver written comments to the Manager, Product
Classification, U.S. Postal Service, 475 L'Enfant Plaza SW, Room 4446,
Washington, DC 20260-3436. Email comments, containing the name and
address of the Commenter, may be sent to: [email protected],
with a subject line of ``E-Cigarette Restrictions.'' Faxed comments are
not accepted. All submitted comments and attachments are part of the
public record and subject to disclosure. Do not enclose any material in
your comments that you consider to be confidential or inappropriate for
public disclosure.
You may inspect and photocopy all written comments, by appointment
only, at USPS[supreg] Headquarters Library, 475 L'Enfant Plaza SW, 11th
Floor North, Washington, DC 20260. These records are available for
review Monday through Friday, 9 a.m. and 4 p.m. by calling 202-268-
2906.
FOR FURTHER INFORMATION CONTACT: Dale E. Kennedy, 202-268-6592.
SUPPLEMENTARY INFORMATION: The Postal Service is proposing to amend
Publication 52 with the provisions described below and, once adopted,
will incorporate the revised Publication 52 by reference into 39 CFR
part 113. You may view the text of the proposed edits to Publication 52
at https://pe.usps.com.
On December 27, 2020, the Preventing Online Sales of E-Cigarettes
to Children Act (``Act''), Public Law 116-160, div. FF, title VI
(2020), was enacted. Effective 90 days after enactment, Section 602 of
the Act adds ``electronic nicotine delivery systems'' (ENDS) to the
definition of ``cigarettes'' subject to regulation under the Jenkins
Act, 15 U.S.C. 375 et seq. Consequently, ENDS will also become subject
to the mailability restrictions and exceptions in 18 U.S.C. 1716E,
which rely on the Jenkins Act definition of ``cigarettes.'' 18 U.S.C.
1716E(a)(1). Section 603 of the Act requires the Postal Service to
promulgate implementing regulations not later than 120 days after
enactment and provides that the prohibition on mailing ENDS will apply
immediately ``on and after'' the date of the final rule.
Current Mailing Restrictions on Cigarettes and Smokeless Tobacco
Currently, 18 U.S.C. 1716E bans the mailing of cigarettes and
smokeless tobacco except in narrowly defined circumstances, as
described below.
Noncontiguous States: Intrastate shipments within Alaska
or Hawaii;
Business/Regulatory Purposes: Shipments transmitted
between verified and authorized tobacco industry businesses for
business purposes, or between such businesses and federal or state
agencies for regulatory purposes;
Certain Individuals: Lightweight shipments mailed between
adult individuals, limited to 10 per 30-day period;
Consumer Testing: Limited shipments of cigarettes sent by
verified and authorized manufacturers to adult smokers for consumer
testing purposes; and
Public Health: Limited shipments by federal agencies for
public health purposes under similar rules applied to manufacturers
conducting consumer testing.
18 U.S.C. 1716E(b)(2)-(6). Outside of these exceptions, the Postal
Service cannot accept or transmit any package that it knows, or has
reasonable cause to believe, contains nonmailable smokeless tobacco or
cigarettes. Id. at (a)(1).
[[Page 10219]]
The Postal Service has determined that the exceptions above cannot
feasibly be applied to inbound or outbound international mail, mail to
or from the Freely Associated States, or mail presented at overseas
Army Post Office (APO), Fleet Post Office (FPO), or Diplomatic Post
Office (DPO) locations and destined to addresses in the United States.
Publication 52, Hazardous, Restricted and Perishable Mail 472.2. As
such, all cigarettes and smokeless tobacco in such mail are
nonmailable, without exception.
Nonmailable cigarettes and smokeless tobacco deposited in the mail
are subject to seizure and forfeiture. 18 U.S.C. 1716E(c). Senders of
nonmailable cigarettes or smokeless tobacco are subject to criminal
fines, imprisonment, and civil penalties, in addition to enforcement
under other federal, state, and local laws. Id. at (d), (e), (h).
Definition of ENDS
The proposed rule uses the definition of ENDS contained in 15
U.S.C. 375(7), as amended by section 602(a)(1)(C) of the Act. Under
this definition, an ENDS is any electronic device that, through an
aerosolized solution, delivers nicotine, flavor, or any other substance
to the user inhaling from the device. Examples include e-cigarettes, e-
hookahs, e-cigars, vape pens, advanced refillable personal vaporizers,
and electronic pipes. Provisions relating to ENDS also extend to any
component, liquid, part, or accessory of an ENDS, regardless of whether
sold separately from the device. Despite the name, an item can qualify
as an ENDS without regard to whether it contains or is intended to be
used to deliver nicotine; liquids that do not actually contain nicotine
can still qualify as ENDS, as can devices, parts, components, and
accessories capable of or intended for use with non-nicotine-containing
liquids.
Excluded from the statutory definition are products approved by the
Food and Drug Administration for sale as tobacco cessation products or
for other therapeutic purposes and marketed and sold solely for such
purposes. Accordingly, the proposed rule excludes such items from the
definition of ENDS. Approved tobacco cessation and therapeutic products
thus remain mailable in domestic mail, international mail, mail treated
as domestic, and mail from overseas APO/FPO/DPO addresses to United
States destination addresses.
Extension of Existing Provisions to ENDS in General; Terminology
In general, the proposed rule would extend the current treatment of
cigarettes and smokeless tobacco to ENDS. This is consistent with how
the Act formally includes ENDS within the definition of ``cigarettes''
in 15 U.S.C. 375(2)(A)(ii), which is used in 18 U.S.C. 1716E.
Consequently, all existing restrictions on and exceptions for
``cigarettes'' apply to ENDS, except where context indicates otherwise.
It is not intuitive that ENDS should be understood as a form of
``cigarette.'' In general parlance, ``cigarettes'' most commonly
consist of ground leaf tobacco wrapped in paper, which deliver nicotine
to a smoker when solid matter is combusted, and the resulting smoke
inhaled. ENDS are electronic devices and their components and fillers,
which deliver either nicotine or non-nicotine substances to a user when
a liquid is vaporized, and the resulting vapor inhaled. To facilitate
understanding by readers not versed in the statute, we propose to treat
ENDS as a standalone category, albeit one generally subject to the same
restrictions and exceptions as cigarettes, consistent with the statute.
We have considered two ways in which to express this generally
equivalent treatment. First, cigarettes, ENDS, and smokeless tobacco
could be listed serially in every applicable instance; however, this
option appears to unduly clutter the rules' text. Second, we could
employ a shorthand term to encompass all three types of items. Indeed,
the statute itself appears to take this approach. Although the term is
not defined in either 18 U.S.C. 1716E or 15 U.S.C. 375, ``tobacco
product'' is used in the title of 18 U.S.C. 1716E and throughout its
text as apparent shorthand for the products made nonmailable by that
section (i.e., cigarettes and smokeless tobacco). Because ENDS now fall
within that scope through their inclusion in the pertinent statutory
definition of ``cigarettes,'' it seems reasonable to use the umbrella
term ``tobacco product'' to refer to ENDS as well as cigarettes and
smokeless tobacco. Hence, we propose to add a definition of ``tobacco
products'' and to replace numerous instances of ``cigarettes and
smokeless tobacco'' with ``tobacco products.''
This proposed solution admittedly shares some of the same
conceptual difficulty discussed above in relation to cigarettes:
Technically speaking, ENDS are not products derived from tobacco. In
this instance, however, the general conceptual alignment, together with
the benefits of a shorthand term and consistency with the statute's use
of the term, appear to weigh in favor of ``tobacco product'' in
reference to all products nonmailable under 18 U.S.C. 1716E. Commenters
are invited to propose alternative terminological approaches and to
discuss the relative merits of their proposals.
Standards for Determining Nonmailability
Current law requires the Postal Service to treat shipments of
cigarettes and smokeless tobacco as nonmailable not only where Postal
Service personnel have actual knowledge that a shipment contains such
items, but also where Postal Service personnel have ``reasonable cause
to believe'' that such contents are present. 18 U.S.C. 1716E(a)(1).
``Reasonable cause'' exists where a party is on the U.S. Attorney
General's List of Unregistered or Noncompliant Delivery Sellers, and
where public statements or advertisements indicate an intent to mail
nonmailable cigarettes or smokeless tobacco for payment. Id. at (a)(2).
The statute's use of ``includes'' before these enumerations of
``reasonable cause'' plainly indicates that the list is illustrative,
rather than exhaustive, but it is silent on what else constitutes
``reasonable cause.'' Beyond those enumerated indicia of suspicion,
other circumstances pertaining to a mailpiece may give rise to a
reasonable suspicion that a package contains nonmailable cigarettes,
smokeless tobacco, or ENDS. Where Postal Service personnel observe such
circumstances and determine that reasonable cause exists, they may
treat a package as nonmailable. The proposed rule would make this
explicit.
In the specific context of ENDS, the new statutory definition
conditions mailability on factors that are extrinsic to the physical
item: Namely, whether a product is FDA-approved for therapeutic or
tobacco-cessation use, and whether it is marketed and sold exclusively
for such purposes. These circumstances are known or knowable by a
mailer, but they are not necessarily apparent to Postal Service
personnel reviewing a package. If the possessor of an FDA-approved and
exclusively marketed therapeutic or tobacco-cessation product wishes to
mail it, then that person has the unique means and incentive to provide
adequate information with the package so that Postal Service personnel
can identify the otherwise nonmailable item as, in fact, mailable. If a
mailer does not do so, then the Postal Service has no basis to
disbelieve indicia indicating the presence of a nonmailable ENDS.
In expecting the mailer to supply such information, the Postal
Service must be able to verify that the mailer is acting in good faith
and not illegitimately treating the therapeutic/tobacco-cessation
[[Page 10220]]
exclusion as an opportunity to evade the general mailing ban. If the
mailer's claim to the exclusion is not appropriately credible or
verifiable, then that claim may not be sufficient to deprive the Postal
Service of reasonable cause to believe that the item is a nonmailable
ENDS. Therefore, the proposed rule would authorize Postal Service
personnel, upon reasonable cause to believe that a package contains
cigarettes, smokeless tobacco, or ENDS, to treat the package as
nonmailable unless the customer has affirmatively, credibly, and
verifiably indicated that the relevant contents are, in fact, mailable.
Commenters are invited to offer their views on this proposed
standard for reasonable cause in connection with ENDS-type items (or
any other tobacco products). To the extent that commenters might
propose alternative standards, commenters are advised to account
specifically for the need to prevent abuse of the narrow exclusion of
therapeutic and tobacco-cessation products; the asymmetry between
mailers' and the Postal Service's access to information about the FDA-
approval status and marketing of particular products; the Postal
Service's limited resources; and its limited legal authority to open
mailpieces that are sent in sealed mail classes without a warrant. 39
U.S.C. 404(c); 39 CFR 233.3(c)(3)-(4), (g)(1)-(2).
Applicability of Exceptions
The existing Noncontiguous States, Business/Regulatory Purposes,
and Certain Individuals exceptions appear to be articulated in terms
that can apply to ENDS as well as to cigarettes and smokeless tobacco.
As such, the proposed use of the umbrella term ``tobacco products'' in
the rules for each exception would automatically apply all such
existing rules to ENDS. Commenters are nonetheless invited to identify
any potential anomalies or other problems that this approach might
create and to recommend solutions for such problems.
The Consumer Testing and Public Health exceptions apply only to
``cigarettes,'' and not to smokeless tobacco. 18 U.S.C. 1716E(b)(5)-
(6). As noted earlier, the Act technically includes ENDS within the
relevant definition of ``cigarettes.'' Without more, this would
ordinarily indicate that these exceptions should apply to ENDS as well
as other forms of ``cigarettes.'' However, 18 U.S.C. 1716E(b)(5)(A)(ii)
or (C)(ii)(III) confine the exceptions to packages containing ``not
more than 12 packs of cigarettes (240 cigarettes).'' Congress did not
amend these provisions when it included ENDS, broadly defined, in the
definition of ``cigarettes,'' and neither the text of the Act nor its
legislative history contains any guidance as to how these conditions
should apply to ENDS.
ENDS are not packaged in such standard quantities as traditional
cigarettes. ENDS rely on devices that can be used in an open-ended
fashion, with potentially limitless quantities of liquid filled
cartridges, whereas traditional cigarettes are self-contained, single-
use items. Moreover, ENDS filler liquids can contain varying quantities
of nicotine, or even no nicotine, whereas cigarettes uniformly contain
nicotine. As such, it does not appear possible even to devise an
administrable standard of equivalence that would allow ``12 packs of
cigarettes (240 cigarettes)'' to be translated into some quantity of
ENDS filler liquid, let alone ENDS products other than filler liquid.
Given the Act's broad definition of ENDS and the material
differences between ENDS products and the types of products originally
encompassed by the Consumer Testing and Public Health exceptions, it
appears reasonable to construe the lack of accommodation for ENDS in
the relevant statutory text to render those exceptions inapplicable to
ENDS. To the extent that commenters believe that the Consumer Testing
and Public Health exceptions should apply to ENDS, commenters are
invited to recommend alternative standards consistent with Congress's
apparent intent to limit the quantity of items mailed in packages under
the exceptions. Commenters should explain in detail how any proposed
alternative quantity limits are analogous to or otherwise consistent
with those in 18 U.S.C. 1716E(b)(5)(A)(ii) or (C)(ii)(III), or why such
consistency is not necessary. Commenters are also invited to furnish
any relevant documentation or supporting information that may aid the
Postal Service in evaluating their recommendations.
Effective Date of Eventual Final Rule
Particularities here merit a brief discussion of the timing of the
eventual final rule, in the interest of providing stakeholders with
advance information. Section 603(a) of the Act requires the Postal
Service ``promulgate regulations to clarify the applicability of the
prohibition on mailing of cigarettes'' to ENDS not later than 120 days
after enactment (i.e., April 26, 2021). Section 603(b) provides that
the prohibition will apply to mailings of ENDS ``on and after'' the
publication date of the final rule. In specifying this immediate
effective date, Congress expressly abrogated the standard 30-day notice
period for a final rule under the Administrative Procedure Act (APA),
which would otherwise apply to rulemakings concerning the mailability
statute here. 5 U.S.C. 553(d), 559; 39 U.S.C. 3001(m). To the extent
that this rulemaking concerns not only the mailing prohibition
referenced in the Act, but also the application of exemptions from that
prohibition, the APA permits those aspects of the eventual final rule
likewise to take effect with less than 30 days' notice (e.g.,
immediately upon publication). 5 U.S.C. 553(d)(1).
Joshua J. Hofer,
Attorney, Ethics and Legal Compliance.
[FR Doc. 2021-03393 Filed 2-17-21; 11:15 am]
BILLING CODE 7710-12-P