Treatment of E-Cigarettes in the Mail, 20287-20289 [2021-07976]

Download as PDF Federal Register / Vol. 86, No. 73 / Monday, April 19, 2021 / Rules and Regulations Regulatory Analyses The Department of State is publishing this rulemaking as a final rule, pursuant to 5 U.S.C. 553(b). This rulemaking is a rule of agency organization, procedure, or practice. The effective date of the rule is 30 days after publication, as provided in the Administrative Procedure Act. The Department further finds that this is not a major rule; is not subject to the Unfunded Mandates Reform Act of 1995; will not have tribal implications as defined by Executive Order 13175; and will not have an impact on a substantial number of small entities under the Regulatory Flexibility Act. This rule is not an economically significant rule under Executive Order 12866, and the Department certifies that the benefits of this rulemaking outweigh any costs, which are minimal for the public. The Office of Information and Regulatory Affairs designated this rule as ‘‘non-significant,’’ as defined by Executive Order 12866. The Department of State has reviewed this rule in light of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden. This rule will not have substantial direct effect on the states, on the relationships between the National Government and the states, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. This rulemaking does not create or modify any collections of information subject to the Paperwork Reduction Act. List of Subjects in 22 CFR Part 62 Cultural exchange programs, Reporting and recordkeeping requirements. For the reasons set forth above, the Department of State amends part 62 of title 22 of the Code of Federal Regulations as follows: 1. The authority citation for part 62 is revised to read as follows: jbell on DSKJLSW7X2PROD with RULES ■ Authority: 8 U.S.C. 1101(a)(15)(J), 1182, 1184, 1258; 22 U.S.C. 1431 et seq.; 22 U.S.C. 2451 et seq.; 22 U.S.C. 2651a; 22 U.S.C. 6531–6553; Reorganization Plan No. 2 of 1977, 42 FR 62461, 3 CFR, 1977 Comp. p. 200; E.O. 12048, 43 FR 13361, 3 CFR, 1978 Comp., p. 168; 8 U.S.C. 1372; section 416 of Pub. L. 107–56, 115 Stat. 354 (8 U.S.C. 1372 note); and 8 U.S.C. 1761–1762. 16:00 Apr 16, 2021 Jkt 253001 § 62.27 Alien physicians. * * * * * (e) * * * (1) The duration of an alien physician’s participation in a program of graduate medical education or training as described in paragraph (b) of this section is limited to the time typically required to complete such program. Duration shall be determined by the Secretary of State at the time of the alien physician’s entry into the United States. Such determination shall be based on criteria established in coordination with the Secretary of Health and Human Services and which take into consideration the requirements of the various medical specialty boards as set forth by the Accreditation Council for Graduate Medical Education (ACGME). * * * * * (4) * * * (i) Alien physicians shall be permitted to undertake graduate medical education or training in a specialty or subspecialty program whose board and/ or accreditation requirements are not published if the program requirements are certified to the Secretary of State by the ACGME in accordance with criteria established by the Educational Commission for Foreign Medical Graduates (ECFMG) and ACGME. * * * * * Zachary A. Parker, Director, Office of Directives Management, Department of State. [FR Doc. 2021–07537 Filed 4–16–21; 8:45 am] BILLING CODE 4710–05–P POSTAL SERVICE 39 CFR Part 113 Treatment of E-Cigarettes in the Mail Postal ServiceTM. Guidance. AGENCY: ACTION: A forthcoming final rule will determine whether electronic nicotine delivery systems (‘‘ENDS’’) may continue to be mailed pursuant to certain statutory exceptions that are currently administered through an application process. To the extent that such exceptions may ultimately be made available for ENDS, this document provides mailers with guidance to assist in preparing exception applications for submission following the final rule. In addition, ENDS mailers are advised to review and comply with all other SUMMARY: PART 62—EXCHANGE VISITOR PROGRAM VerDate Sep<11>2014 2. Section 62.27(e)(1) and (e)(4)(i) are revised to read as follows: ■ PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 20287 applicable mailing restrictions and requirements currently in effect for controlled substances, drug paraphernalia, and hazardous materials. DATES: April 19, 2021. FOR FURTHER INFORMATION CONTACT: Dale E. Kennedy, 202–268–6592. SUPPLEMENTARY INFORMATION: On February 19, 2021 (86 FR 10218), the Postal Service published a notice of proposed rulemaking to amend Publication 52, Hazardous, Restricted, and Perishable Mail, which is incorporated by reference into 39 CFR part 113. The text of the proposed edits to Publication 52 is available at https:// pe.usps.com/FederalRegisterNotice/ 2021/E-Cigarettes%20Proposed% 20Rule.pdf. The proposed edits would implement the Preventing Online Sales of E-Cigarettes to Children Act (‘‘Act’’), Public Law 116–160, div. FF, title VI (2020), which 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 (‘‘PACT Act’’), which rely on the Jenkins Act definition of ‘‘cigarettes.’’ 18 U.S.C. 1716E(a)(1). Certain such exceptions currently require application to and approval by the Postal Service’s Pricing and Classification Service Center. See Publication 52 sections 472.221 (business/regulatory purposes), 472.241 (consumer testing/public health). The Postal Service proposed to apply the business/regulatory purposes exception to ENDS, but not the consumer testing and public health exceptions, and invited comments on that proposed approach. Those comments will be considered in developing the final rule. The final rule will contain the Postal Service’s determination as to whether any of those exceptions will be made available for nonmailable ENDS. Until the final rule is issued, ENDS are not subject to the PACT Act, although they may be nonmailable for other reasons. See, e.g., 18 U.S.C. 1716(a), (h) (poisonous, explosive, and other dangerous materials, and advertising, promotional, or sales matter relating to the same); 21 U.S.C. 843(b)– (c), 863 (controlled substances, drug paraphernalia, and advertisements relating to the same); 39 U.S.C. 3018 (hazardous materials); Publication 52 sections 31–349, 453 & appx. A, C. Regardless of the legal status of any products under state or local laws, violations of these Federal mailability laws can result in civil and/or criminal penalties. E:\FR\FM\19APR1.SGM 19APR1 20288 Federal Register / Vol. 86, No. 73 / Monday, April 19, 2021 / Rules and Regulations jbell on DSKJLSW7X2PROD with RULES The Postal Service has received numerous inquiries and comments about the possibility of submitting exception applications for ENDS products in advance of the final rule. Several commenters express the ENDS industry’s concerns about the continuity of supply chains and regulatory compliance activities that rely on the mails, to the extent that such reliance may permissibly continue under the PACT Act. The Postal Service understands that those concerns are heightened by Congress’s decision to make ENDS nonmailable immediately upon publication of the final rule, rather than applying the 30-day notice period that typically follows a final rule under the Administrative Procedure Act. Therefore, this document is intended to clarify the state of the exception application process in advance of the final rule and to provide guidance to mailers interested in availing themselves of any exceptions that may ultimately be made available. Exception Application Process; Preparatory Guidance The Postal Service cannot accept early applications for PACT Act exceptions relating to ENDS products at this time. The Postal Service has not yet determined whether and to what extent those exceptions will be extended to ENDS. Early acceptance of applications would pose significant administrative challenges for the very Postal Service personnel who are developing the final rule amid substantial public comment under a tight timeframe. If any of the relevant exceptions are ultimately made available for ENDS, then, given the highly decentralized nature of the ENDS industry relative to the industries historically covered by the PACT Act, the Postal Service anticipates receiving ENDS-related exception applications at a rate several orders of magnitude above the historic norm. Moreover, those applications are expected to involve numbers of parties and products far greater than past PACT Act applications. These factors translate into a load on Postal Service resources that would massively outstrip historically allocated levels. The Postal Service is contemplating reforms to its application process to contend with this manifold near-term increase in complexity that would result from extending the exceptions to ENDS, as well as studying how to improve the process’s efficiency and accessibility in the longer term. Whether any ENDS mailers may ultimately be allowed to use the exceptions remains to be determined. The Postal Service is not in an VerDate Sep<11>2014 16:00 Apr 16, 2021 Jkt 253001 administrative position to begin accepting ENDS-related exception applications at this time, and it may not be in such a position until issuance of the final rule. If, contrary to expectation, circumstances permit earlier acceptance of ENDS-related exception applications on a provisional basis, the Postal Service will issue further notice to that effect. If the final rule does make the business/regulatory purposes and/or consumer testing/public health exceptions available for ENDS and applications are accepted through a reorganized process, applicants should expect review of their applications to require potentially substantial processing time, in light of the statutory requirements for Postal Service verification of mailers’ and recipients’ eligibility. 18 U.S.C. 1716E(b)(3)(B)(ii)(I)–(II), (b)(5)(C)(ii)(I). The duration of any review would be determined by the number and complexity of the applications that the Postal Service receives and the amount of engagement with applicants during processing. The following guidance is aimed at facilitating Postal Service review and potentially reducing processing times for any potential exception applications relating to ENDS, should they be permitted under the final rule. Documentation. With respect to the relevant exceptions, the PACT Act requires the Postal Service to verify mailers’ and recipients’ eligibility, which includes whether they are ‘‘legally operating’’, ‘‘have all applicable State and Federal Government licenses or permits and are engaged in tobacco product manufacturing, distribution, wholesale, export, import, testing, investigation, or research.’’ 18 U.S.C. 1716E(b)(3)(A)(i), (b)(3)(B)(ii)(I)–(II), (b)(5)(A), (b)(5)(C)(ii)(I). Applicants for the consumer testing exception must also be (or be legally authorized agents of) legally operating cigarette manufacturers with ‘‘a permit, in good standing, issued under section 5713 of the Internal Revenue Code of 1986.’’ Id. at (b)(5)(A)(i). To the extent that the final rule may make any of these exceptions available for shipments of ENDS, prospective applicants may wish to prepare by compiling electronic copies of all relevant license and permit documentation for themselves and, with respect to the business/regulatory purposes exception, each addressee that they intend to identify in their exception application. For intended business/regulatory purposes exception applications by organizations engaged in testing, PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 investigation, or research and those listing such organizations as addressees, relevant documentation may include such materials that would demonstrate the organizations’ authorization to engage in the relevant activities (e.g., grant or contract approval documents showing the scope and duration of a relevant research project). Indexing. Prospective applicants for the business/regulatory purposes exception should prepare a spreadsheet that contains the following data elements with respect to each sender and recipient address that they intend to identify in their exception application: a. Business or governmental entity name. b. Address. c. The Postal Service retail or business mail acceptance office(s) where each intended sender would tender shipments. d. The Postal Service retail office(s) where each intended recipient would retrieve shipments. e. A description of the business or governmental entity (e.g., battery manufacturer, retail store, wholesale distributor, testing laboratory). f. For each permit or license, the issuing jurisdiction; the permit or license number; the expiration date (if any); and the activity covered by each current permit or license (e.g., general business operations; sale or manufacture of tobacco products or ENDS). g. For each sender or addressee engaged in testing, investigation, or research, the entities authorizing the conduct of such activities; the expiration date (if any) of such authorization; and a brief statement of the subject of each authorization (e.g., health effects of flavor substances, medical effects of cannabidiol (‘‘CBD’’), battery safety testing). h. The brand name and a description of each product intended to be shipped by each sender or to each addressee. i. Whether any identified products or other intended shipments from each sender or to each addressee contain lithium batteries, nicotine, CBD, or tetrahydrocannabinol (‘‘THC’’). j. For products containing nicotine or THC, the intended quantity of the product per shipment and the concentration of nicotine or THC. k. For products containing CBD with a THC concentration not exceeding 0.3 percent, whether the CBD derives from hemp. Mailability Beyond the PACT Act ENDS implicate mailability statutes and regulations beyond the PACT Act. These statutes and regulations already E:\FR\FM\19APR1.SGM 19APR1 jbell on DSKJLSW7X2PROD with RULES Federal Register / Vol. 86, No. 73 / Monday, April 19, 2021 / Rules and Regulations render certain substances and components nonmailable, and they will continue to do so with respect to any ENDS shipments that remain mailable pursuant to exceptions or exclusions under the impending final rule. ENDS that become nonmailable under the PACT Act can additionally violate other mailability statutes and regulations. These restrictions and requirements govern the use of the federal mail system, regardless of the legal status of any items under state or local law. Violations of these mailability laws can result in civil or criminal penalties. Therefore, all persons currently or prospectively engaged in the mailing of ENDS—including, in particular, those who intend to continue mailing ENDS under any potentially available PACT Act exceptions—are advised to review Publication 52 carefully. Certain pertinent issues are highlighted below, but this list is not necessarily exhaustive. CBD products. For hemp-based products containing CBD with a THC concentration not exceeding 0.3 percent, mailers must retain, and prepare to make available upon request, records establishing compliance with all applicable federal, state, and local laws pertaining to hemp production, processing, distribution, and sales, including the Agricultural Act of 2014 and the Agricultural Improvement Act of 2018. Such records may include laboratory test results, licenses, and compliance reports. See Publication 52 section 453.37. Controlled substances and drug paraphernalia. All other substances that contain THC are Schedule I controlled substances for purposes of federal law, 21 CFR 1308.11(d)(31), and are therefore nonmailable in most instances. 21 U.S.C. 843(b); Publication 52 section 453. Products used with such substances may qualify as nonmailable drug paraphernalia. See 21 U.S.C. 863; Publication 52 section 453. This federal mailing prohibition is unaffected by whether the mailing of THC-containing substances violates state or local law and by the restriction of Department of Justice appropriations relating to medical marijuana. See Public Law 116– 260, div. B, title V, section 531 (2020). Advertisements for controlled substances and drug paraphernalia. It is unlawful to mail advertisements for, or to advertise the mailing of, federally controlled substances or drug paraphernalia. 21 U.S.C. 843(b), (c)(1); Mailing Standards of the United States Postal Service, Domestic Mail Manual (‘‘DMM’’) section 601.9.4.1. Hazardous materials: Solutions. Toxic and flammable substances are VerDate Sep<11>2014 16:00 Apr 16, 2021 Jkt 253001 nonmailable except subject to requirements designed to render them nonhazardous in the mails and/or in air transportation. 18 U.S.C. 1716(a)–(b); 39 U.S.C. 3018; Publication 52 sections 31– 349, 711–728 & appx. A, C. Mailers of ENDS solutions should carefully review the chemical constituents of those products and ascertain the flashpoint of each constituent substance, its toxicological profile, and its concentration in the relevant solution. Nicotine is a toxic substance, for example. In addition, ENDS liquids— including non-nicotine-containing liquids—may contain acetals, acetoin (acetyl methyl carbinol), aldehydes, butanol, diacetyl (butanedione), propanol, and other compounds that qualify as flammable or toxic substances. Compare 49 CFR 172.101; Publication 52, appx. A, with Hanno C. Erythropel et al., Formation of Flavorant-Propylene Glycol Adducts with Novel Toxicological Properties in Chemically Unstable E-Cigarette Liquids, 21 Nicotine & Tobacco Research 1248 (2018); Joseph G. Allen et al., Flavoring Chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and Acetoin in a Sample of 51 Products, Including Fruit-, Candy-, and Cocktail-Flavored ECigarettes, 124 Enviro. Health Perspectives 733 (2016). Depending on a substance’s flashpoint or lethal dose (LD50) and its concentration in a solution, the substance may or may not be prohibited or subject to special Department of Transportation requirements as a hazardous material. See generally Publication 52 sections 343, 346 & appx. A, C. Such items may be prohibited from or restricted in air transportation and may not be eligible for shipping via Priority Mail Express, Priority Mail, First-Class Mail, or First-Class Package Service. Id. sections 327, 711–728. Even nonregulated toxic liquids and solids may be subject to quantity restrictions, packaging requirements, and restrictions on the availability of Postal Service shipping options. See Publication 52 sections 346.232. Hazardous materials: Lithium batteries. Mailers of lithium metal or lithium-ion batteries should be aware of applicable restrictions and requirements, which may determine mailability, packaging, product design, shipping quantities, and the availability of relevant Postal Service products. See Publication 52 section 349.221–.222, 711–728. Non-hazardous liquids. Mailers of liquids that are not regulated as hazardous materials (whether or not such liquids contain nicotine) should be aware of applicable packaging PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 20289 requirements. See Publication 52 section 451.3 and DMM section 601.3.4. Hazardous and restricted materials: Advertising, promotional, or sales matter. To the extent that ENDS may be subject to special requirements as hazardous or otherwise restricted materials, then matter that solicits or induces the mailing of such items is mailable only if it contains all pertinent packaging instructions and any other mailing limitations. 18 U.S.C. 1716(h); DMM section 601.9.4.1. Conclusion Again, it is emphasized that the Postal Service has yet to determine whether and to what extent any PACT Act exceptions may be made available for ENDS. Nevertheless, mailers of ENDS products may find the preparatory information above useful in preparing for the potential availability of such exceptions following a final rule. In addition, all persons currently or prospectively engaged in the mailing of ENDS products should carefully review non-PACT-Act-related mailing prohibitions, restrictions, and other requirements that may apply to ENDS products, to ensure that their use of the mail system is safe and compliant with Federal law. Joshua J. Hofer, Attorney, Ethics & Legal Compliance. [FR Doc. 2021–07976 Filed 4–16–21; 8:45 am] BILLING CODE P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA–R06–OAR–2015–0189; FRL–10022– 74–Region 6] Air Plan Approval; Arkansas; Arkansas Regional Haze and Visibility Transport State Implementation Plan Revisions; Correction Environmental Protection Agency (EPA). ACTION: Final rule; correction. AGENCY: The Environmental Protection Agency (EPA) is correcting a final rule that appeared in the Federal Register on March 22, 2021, and that will become effective on April 21, 2021. The EPA finalized approval of a revision to the Arkansas State Implementation Plan (SIP) submitted by the State of Arkansas through the Arkansas Department of Energy and Environment, Division of Environmental Quality (DEQ). This document corrects an error in the regulatory text. This correction does not SUMMARY: E:\FR\FM\19APR1.SGM 19APR1

Agencies

[Federal Register Volume 86, Number 73 (Monday, April 19, 2021)]
[Rules and Regulations]
[Pages 20287-20289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-07976]


=======================================================================
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POSTAL SERVICE

39 CFR Part 113


Treatment of E-Cigarettes in the Mail

AGENCY: Postal ServiceTM.

ACTION: Guidance.

-----------------------------------------------------------------------

SUMMARY: A forthcoming final rule will determine whether electronic 
nicotine delivery systems (``ENDS'') may continue to be mailed pursuant 
to certain statutory exceptions that are currently administered through 
an application process. To the extent that such exceptions may 
ultimately be made available for ENDS, this document provides mailers 
with guidance to assist in preparing exception applications for 
submission following the final rule. In addition, ENDS mailers are 
advised to review and comply with all other applicable mailing 
restrictions and requirements currently in effect for controlled 
substances, drug paraphernalia, and hazardous materials.

DATES: April 19, 2021.

FOR FURTHER INFORMATION CONTACT: Dale E. Kennedy, 202-268-6592.

SUPPLEMENTARY INFORMATION: On February 19, 2021 (86 FR 10218), the 
Postal Service published a notice of proposed rulemaking to amend 
Publication 52, Hazardous, Restricted, and Perishable Mail, which is 
incorporated by reference into 39 CFR part 113. The text of the 
proposed edits to Publication 52 is available at https://pe.usps.com/FederalRegisterNotice/2021/E-Cigarettes%20Proposed%20Rule.pdf. The 
proposed edits would implement the Preventing Online Sales of E-
Cigarettes to Children Act (``Act''), Public Law 116-160, div. FF, 
title VI (2020), which 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 (``PACT Act''), which rely on the Jenkins Act 
definition of ``cigarettes.'' 18 U.S.C. 1716E(a)(1).
    Certain such exceptions currently require application to and 
approval by the Postal Service's Pricing and Classification Service 
Center. See Publication 52 sections 472.221 (business/regulatory 
purposes), 472.241 (consumer testing/public health). The Postal Service 
proposed to apply the business/regulatory purposes exception to ENDS, 
but not the consumer testing and public health exceptions, and invited 
comments on that proposed approach. Those comments will be considered 
in developing the final rule. The final rule will contain the Postal 
Service's determination as to whether any of those exceptions will be 
made available for nonmailable ENDS.
    Until the final rule is issued, ENDS are not subject to the PACT 
Act, although they may be nonmailable for other reasons. See, e.g., 18 
U.S.C. 1716(a), (h) (poisonous, explosive, and other dangerous 
materials, and advertising, promotional, or sales matter relating to 
the same); 21 U.S.C. 843(b)-(c), 863 (controlled substances, drug 
paraphernalia, and advertisements relating to the same); 39 U.S.C. 3018 
(hazardous materials); Publication 52 sections 31-349, 453 & appx. A, 
C. Regardless of the legal status of any products under state or local 
laws, violations of these Federal mailability laws can result in civil 
and/or criminal penalties.

[[Page 20288]]

    The Postal Service has received numerous inquiries and comments 
about the possibility of submitting exception applications for ENDS 
products in advance of the final rule. Several commenters express the 
ENDS industry's concerns about the continuity of supply chains and 
regulatory compliance activities that rely on the mails, to the extent 
that such reliance may permissibly continue under the PACT Act. The 
Postal Service understands that those concerns are heightened by 
Congress's decision to make ENDS nonmailable immediately upon 
publication of the final rule, rather than applying the 30-day notice 
period that typically follows a final rule under the Administrative 
Procedure Act. Therefore, this document is intended to clarify the 
state of the exception application process in advance of the final rule 
and to provide guidance to mailers interested in availing themselves of 
any exceptions that may ultimately be made available.

Exception Application Process; Preparatory Guidance

    The Postal Service cannot accept early applications for PACT Act 
exceptions relating to ENDS products at this time. The Postal Service 
has not yet determined whether and to what extent those exceptions will 
be extended to ENDS. Early acceptance of applications would pose 
significant administrative challenges for the very Postal Service 
personnel who are developing the final rule amid substantial public 
comment under a tight timeframe.
    If any of the relevant exceptions are ultimately made available for 
ENDS, then, given the highly decentralized nature of the ENDS industry 
relative to the industries historically covered by the PACT Act, the 
Postal Service anticipates receiving ENDS-related exception 
applications at a rate several orders of magnitude above the historic 
norm. Moreover, those applications are expected to involve numbers of 
parties and products far greater than past PACT Act applications. These 
factors translate into a load on Postal Service resources that would 
massively outstrip historically allocated levels. The Postal Service is 
contemplating reforms to its application process to contend with this 
manifold near-term increase in complexity that would result from 
extending the exceptions to ENDS, as well as studying how to improve 
the process's efficiency and accessibility in the longer term.
    Whether any ENDS mailers may ultimately be allowed to use the 
exceptions remains to be determined. The Postal Service is not in an 
administrative position to begin accepting ENDS-related exception 
applications at this time, and it may not be in such a position until 
issuance of the final rule. If, contrary to expectation, circumstances 
permit earlier acceptance of ENDS-related exception applications on a 
provisional basis, the Postal Service will issue further notice to that 
effect.
    If the final rule does make the business/regulatory purposes and/or 
consumer testing/public health exceptions available for ENDS and 
applications are accepted through a reorganized process, applicants 
should expect review of their applications to require potentially 
substantial processing time, in light of the statutory requirements for 
Postal Service verification of mailers' and recipients' eligibility. 18 
U.S.C. 1716E(b)(3)(B)(ii)(I)-(II), (b)(5)(C)(ii)(I). The duration of 
any review would be determined by the number and complexity of the 
applications that the Postal Service receives and the amount of 
engagement with applicants during processing.
    The following guidance is aimed at facilitating Postal Service 
review and potentially reducing processing times for any potential 
exception applications relating to ENDS, should they be permitted under 
the final rule.
    Documentation. With respect to the relevant exceptions, the PACT 
Act requires the Postal Service to verify mailers' and recipients' 
eligibility, which includes whether they are ``legally operating'', 
``have all applicable State and Federal Government licenses or permits 
and are engaged in tobacco product manufacturing, distribution, 
wholesale, export, import, testing, investigation, or research.'' 18 
U.S.C. 1716E(b)(3)(A)(i), (b)(3)(B)(ii)(I)-(II), (b)(5)(A), 
(b)(5)(C)(ii)(I). Applicants for the consumer testing exception must 
also be (or be legally authorized agents of) legally operating 
cigarette manufacturers with ``a permit, in good standing, issued under 
section 5713 of the Internal Revenue Code of 1986.'' Id. at 
(b)(5)(A)(i).
    To the extent that the final rule may make any of these exceptions 
available for shipments of ENDS, prospective applicants may wish to 
prepare by compiling electronic copies of all relevant license and 
permit documentation for themselves and, with respect to the business/
regulatory purposes exception, each addressee that they intend to 
identify in their exception application.
    For intended business/regulatory purposes exception applications by 
organizations engaged in testing, investigation, or research and those 
listing such organizations as addressees, relevant documentation may 
include such materials that would demonstrate the organizations' 
authorization to engage in the relevant activities (e.g., grant or 
contract approval documents showing the scope and duration of a 
relevant research project).
    Indexing. Prospective applicants for the business/regulatory 
purposes exception should prepare a spreadsheet that contains the 
following data elements with respect to each sender and recipient 
address that they intend to identify in their exception application:
    a. Business or governmental entity name.
    b. Address.
    c. The Postal Service retail or business mail acceptance office(s) 
where each intended sender would tender shipments.
    d. The Postal Service retail office(s) where each intended 
recipient would retrieve shipments.
    e. A description of the business or governmental entity (e.g., 
battery manufacturer, retail store, wholesale distributor, testing 
laboratory).
    f. For each permit or license, the issuing jurisdiction; the permit 
or license number; the expiration date (if any); and the activity 
covered by each current permit or license (e.g., general business 
operations; sale or manufacture of tobacco products or ENDS).
    g. For each sender or addressee engaged in testing, investigation, 
or research, the entities authorizing the conduct of such activities; 
the expiration date (if any) of such authorization; and a brief 
statement of the subject of each authorization (e.g., health effects of 
flavor substances, medical effects of cannabidiol (``CBD''), battery 
safety testing).
    h. The brand name and a description of each product intended to be 
shipped by each sender or to each addressee.
    i. Whether any identified products or other intended shipments from 
each sender or to each addressee contain lithium batteries, nicotine, 
CBD, or tetrahydrocannabinol (``THC'').
    j. For products containing nicotine or THC, the intended quantity 
of the product per shipment and the concentration of nicotine or THC.
    k. For products containing CBD with a THC concentration not 
exceeding 0.3 percent, whether the CBD derives from hemp.

Mailability Beyond the PACT Act

    ENDS implicate mailability statutes and regulations beyond the PACT 
Act. These statutes and regulations already

[[Page 20289]]

render certain substances and components nonmailable, and they will 
continue to do so with respect to any ENDS shipments that remain 
mailable pursuant to exceptions or exclusions under the impending final 
rule. ENDS that become nonmailable under the PACT Act can additionally 
violate other mailability statutes and regulations. These restrictions 
and requirements govern the use of the federal mail system, regardless 
of the legal status of any items under state or local law. Violations 
of these mailability laws can result in civil or criminal penalties. 
Therefore, all persons currently or prospectively engaged in the 
mailing of ENDS--including, in particular, those who intend to continue 
mailing ENDS under any potentially available PACT Act exceptions--are 
advised to review Publication 52 carefully. Certain pertinent issues 
are highlighted below, but this list is not necessarily exhaustive.
    CBD products. For hemp-based products containing CBD with a THC 
concentration not exceeding 0.3 percent, mailers must retain, and 
prepare to make available upon request, records establishing compliance 
with all applicable federal, state, and local laws pertaining to hemp 
production, processing, distribution, and sales, including the 
Agricultural Act of 2014 and the Agricultural Improvement Act of 2018. 
Such records may include laboratory test results, licenses, and 
compliance reports. See Publication 52 section 453.37.
    Controlled substances and drug paraphernalia. All other substances 
that contain THC are Schedule I controlled substances for purposes of 
federal law, 21 CFR 1308.11(d)(31), and are therefore nonmailable in 
most instances. 21 U.S.C. 843(b); Publication 52 section 453. Products 
used with such substances may qualify as nonmailable drug 
paraphernalia. See 21 U.S.C. 863; Publication 52 section 453. This 
federal mailing prohibition is unaffected by whether the mailing of 
THC-containing substances violates state or local law and by the 
restriction of Department of Justice appropriations relating to medical 
marijuana. See Public Law 116-260, div. B, title V, section 531 (2020).
    Advertisements for controlled substances and drug paraphernalia. It 
is unlawful to mail advertisements for, or to advertise the mailing of, 
federally controlled substances or drug paraphernalia. 21 U.S.C. 
843(b), (c)(1); Mailing Standards of the United States Postal Service, 
Domestic Mail Manual (``DMM'') section 601.9.4.1.
    Hazardous materials: Solutions. Toxic and flammable substances are 
nonmailable except subject to requirements designed to render them 
nonhazardous in the mails and/or in air transportation. 18 U.S.C. 
1716(a)-(b); 39 U.S.C. 3018; Publication 52 sections 31-349, 711-728 & 
appx. A, C. Mailers of ENDS solutions should carefully review the 
chemical constituents of those products and ascertain the flashpoint of 
each constituent substance, its toxicological profile, and its 
concentration in the relevant solution. Nicotine is a toxic substance, 
for example. In addition, ENDS liquids--including non-nicotine-
containing liquids--may contain acetals, acetoin (acetyl methyl 
carbinol), aldehydes, butanol, diacetyl (butanedione), propanol, and 
other compounds that qualify as flammable or toxic substances. Compare 
49 CFR 172.101; Publication 52, appx. A, with Hanno C. Erythropel et 
al., Formation of Flavorant-Propylene Glycol Adducts with Novel 
Toxicological Properties in Chemically Unstable E-Cigarette Liquids, 21 
Nicotine & Tobacco Research 1248 (2018); Joseph G. Allen et al., 
Flavoring Chemicals in E-Cigarettes: Diacetyl, 2,3-Pentanedione, and 
Acetoin in a Sample of 51 Products, Including Fruit-, Candy-, and 
Cocktail-Flavored E-Cigarettes, 124 Enviro. Health Perspectives 733 
(2016).
    Depending on a substance's flashpoint or lethal dose 
(LD50) and its concentration in a solution, the substance 
may or may not be prohibited or subject to special Department of 
Transportation requirements as a hazardous material. See generally 
Publication 52 sections 343, 346 & appx. A, C. Such items may be 
prohibited from or restricted in air transportation and may not be 
eligible for shipping via Priority Mail Express, Priority Mail, First-
Class Mail, or First-Class Package Service. Id. sections 327, 711-728. 
Even nonregulated toxic liquids and solids may be subject to quantity 
restrictions, packaging requirements, and restrictions on the 
availability of Postal Service shipping options. See Publication 52 
sections 346.232.
    Hazardous materials: Lithium batteries. Mailers of lithium metal or 
lithium-ion batteries should be aware of applicable restrictions and 
requirements, which may determine mailability, packaging, product 
design, shipping quantities, and the availability of relevant Postal 
Service products. See Publication 52 section 349.221-.222, 711-728.
    Non-hazardous liquids. Mailers of liquids that are not regulated as 
hazardous materials (whether or not such liquids contain nicotine) 
should be aware of applicable packaging requirements. See Publication 
52 section 451.3 and DMM section 601.3.4.
    Hazardous and restricted materials: Advertising, promotional, or 
sales matter. To the extent that ENDS may be subject to special 
requirements as hazardous or otherwise restricted materials, then 
matter that solicits or induces the mailing of such items is mailable 
only if it contains all pertinent packaging instructions and any other 
mailing limitations. 18 U.S.C. 1716(h); DMM section 601.9.4.1.

Conclusion

    Again, it is emphasized that the Postal Service has yet to 
determine whether and to what extent any PACT Act exceptions may be 
made available for ENDS. Nevertheless, mailers of ENDS products may 
find the preparatory information above useful in preparing for the 
potential availability of such exceptions following a final rule. In 
addition, all persons currently or prospectively engaged in the mailing 
of ENDS products should carefully review non-PACT-Act-related mailing 
prohibitions, restrictions, and other requirements that may apply to 
ENDS products, to ensure that their use of the mail system is safe and 
compliant with Federal law.

Joshua J. Hofer,
Attorney, Ethics & Legal Compliance.
[FR Doc. 2021-07976 Filed 4-16-21; 8:45 am]
BILLING CODE P
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