Treatment of E-Cigarettes in the Mail, 10218-10220 [2021-03393]

Download as PDF 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 Register. You may access the official edition of the Federal Register and the Code of Federal Regulations at VerDate Sep<11>2014 18:27 Feb 18, 2021 Jkt 253001 www.govinfo.gov. At this site you can view this document, as well as all other documents of this Department published in the Federal Register, in text or Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site. You may also access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department. David Cantrell, Deputy Commissioner, Office of Special 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: PO 00000 Frm 00008 Fmt 4702 Sfmt 4702 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). E:\FR\FM\19FEP1.SGM 19FEP1 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Proposed Rules tkelley on DSKBCP9HB2PROD with PROPOSALS 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 VerDate Sep<11>2014 18:27 Feb 18, 2021 Jkt 253001 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 PO 00000 Frm 00009 Fmt 4702 Sfmt 4702 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 E:\FR\FM\19FEP1.SGM 19FEP1 10220 Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Proposed Rules tkelley on DSKBCP9HB2PROD with PROPOSALS 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 VerDate Sep<11>2014 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 PO 00000 Frm 00010 Fmt 4702 Sfmt 4702 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 19FEP1

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]


=======================================================================
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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


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