Proposed Rule2024-16716
Banned Hazardous Substances: Aerosol Duster Products Containing More Than 18 mg in Any Combination of HFC-152a and/or HFC-134a
Primary source
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Published
July 31, 2024
Issuing agencies
Consumer Product Safety Commission
Abstract
The U.S. Consumer Product Safety Commission (Commission or CPSC) is proposing to declare that any aerosol duster products that contain more than 18 mg in any combination of HFC-152a and/or HFC-134a are banned hazardous substances under the Federal Hazardous Substances Act (FHSA). For the ten-year period from 2012 to 2021, CPSC is aware of more than 1,000 deaths, and estimates 21,700 treated injuries involving the inhalation of aerosol duster products. The proposed rule addresses deaths and injuries associated with the propellants HFC- 152a and HFC-134a used in aerosol duster products. The Commission is providing an opportunity for interested parties to submit written comments on this notice of proposed rulemaking (NPR).
Full Text
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<title>Federal Register, Volume 89 Issue 147 (Wednesday, July 31, 2024)</title>
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[Federal Register Volume 89, Number 147 (Wednesday, July 31, 2024)]
[Proposed Rules]
[Pages 61363-61381]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16716]
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CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1500
[CPSC Docket No. CPSC-2021-0015]
Banned Hazardous Substances: Aerosol Duster Products Containing
More Than 18 mg in Any Combination of HFC-152a and/or HFC-134a
AGENCY: Consumer Product Safety Commission.
ACTION: Notice of proposed rulemaking.
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SUMMARY: The U.S. Consumer Product Safety Commission (Commission or
CPSC) is proposing to declare that any aerosol duster products that
contain more than 18 mg in any combination of HFC-152a and/or HFC-134a
are banned hazardous substances under the Federal Hazardous Substances
Act (FHSA). For the ten-year period from 2012 to 2021, CPSC is aware of
more than 1,000 deaths, and estimates 21,700 treated injuries involving
the inhalation of aerosol duster products. The proposed
[[Page 61364]]
rule addresses deaths and injuries associated with the propellants HFC-
152a and HFC-134a used in aerosol duster products. The Commission is
providing an opportunity for interested parties to submit written
comments on this notice of proposed rulemaking (NPR).
DATES: Written comments must be received by September 30, 2024.
ADDRESSES:
Written Comments:
Comments related to the Paperwork Reduction Act aspects of the
proposed rule should be directed to the Office of Information and
Regulatory Affairs, OMB, Attn: CPSC Desk Officer, FAX: 202-395-6974, or
emailed to <a href="/cdn-cgi/l/email-protection#056a6c77645a767067686c76766c6a6b456a68672b606a752b626a73"><span class="__cf_email__" data-cfemail="127d7b60734d6167707f7b61617b7d7c527d7f703c777d623c757d64">[email protected]</span></a>.
Other written comments in response to the proposed rule, identified
by Docket No. CPSC-2021-0015 may be submitted by any of the following
methods:
Electronic Submissions: Submit electronic comments to the Federal
eRulemaking Portal at: <a href="http://www.regulations.gov">www.regulations.gov</a>. Follow the instructions for
submitting comments. CPSC typically does not accept comments submitted
by email, except as described below. CPSC encourages you to submit
electronic comments by using the Federal eRulemaking Portal, as
described above.
Mail/Hand Delivery/Courier/Written Submissions: Submit comments by
mail/hand delivery/courier to: Office of the Secretary, Consumer
Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814;
telephone: (301) 504-7479. If you wish to submit confidential business
information, trade secret information, or other sensitive or protected
information that you do not want to be available to the public, you may
submit such comments by mail, hand delivery, courier, or you may email
them to: <a href="/cdn-cgi/l/email-protection#36554645551b5945765546455518515940"><span class="__cf_email__" data-cfemail="1c7f6c6f7f31736f5c7f6c6f7f327b736a">[email protected]</span></a>.
Instructions: All submissions must include the agency name and
docket number. CPSC may post all comments without change, including any
personal identifiers, contact information, or other personal
information provided to: <a href="http://www.regulations.gov">www.regulations.gov</a>. Do not submit through
this website: confidential business information, trade secret
information, or other sensitive or protected information that you do
not want to be available to the public. If you wish to submit such
information, please submit it according to the instructions for mail/
hand delivery/courier/written submissions.
Docket for NPR: For access to the docket to read background
documents or comments received, go to: <a href="http://www.regulations.gov">www.regulations.gov</a>, insert the
docket number CPSC-2021-0015 into the ``Search'' box, and follow the
prompts.
FOR FURTHER INFORMATION CONTACT: Mary Kelleher, Directorate for Health
Sciences, Consumer Product Safety Commission, National Product Testing
and Evaluation Center, 5 Research Place, Rockville, MD 20850;
telephone: 240-429-4894; <a href="/cdn-cgi/l/email-protection#5a37313f36363f323f281a392a2939743d352c"><span class="__cf_email__" data-cfemail="0a67616f66666f626f784a697a7969246d657c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In this NPR, the Commission proposes to
declare any aerosol duster canisters containing more than 18 mg of the
hazardous chemicals HFC-152a and/or HFC-134a to be banned hazardous
substances under the FHSA. From 2012 to 2021, inhalation of these
products resulted in 1,039 known deaths and an estimated 21,700
emergency department (ED) treated injuries in the United States.
Although aerosol duster products that do not contain these hazardous
substances would likely be more expensive, over 30 years the proposed
rule is projected to yield net benefits of nearly $2 billion, with more
than 16 dollars of benefit for every dollar of cost. Furthermore,
aerosol duster products will remain available and affordable
alternatives such as electric dusters are also available.
I. Background
On April 2, 2021, Families United Against Inhalant Abuse (FUAIA)
submitted a petition requesting that the Commission initiate rulemaking
to adopt a mandatory safety standard to address the hazards associated
with aerosol duster products used for cleaning electronics and other
items containing the chemical 1,1-difluorethane, or any derivative
thereof. The petition requested CPSC conduct rulemaking to address the
numerous deaths and injuries associated with inhalant abuse of aerosol
duster products. Specifically, the petition requested a performance
standard requiring that manufacturers add an aversive agent (bitterant
other than denatonium benzoate) to all duster aerosol products at a
level of 30-40 ppm, and it requested a required warning stating:
``DANGER: DEATH--This product can kill you if you breath [sic] it.''
\1\
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\1\ The petition is available at <a href="https://www.cpsc.gov/Regulations-Laws--Standards/Rulemaking/Petitions">https://www.cpsc.gov/Regulations-Laws--Standards/Rulemaking/Petitions</a>. The petitioner
also requested that CPSC require retailers to limit multiple duster
can purchases during a one-month time period; the Commission,
however, explained that it does not have rulemaking authority over
such personal purchasing decisions. 86 FR 34171, n.1 (June 29,
2021).
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On June 29, 2021, the Commission published in the Federal Register
a request for comments on the petition. 86 FR 34171. On July 20, 2022,
staff submitted a briefing package to the Commission regarding the
petition.\2\ On July 26, 2022, the Commission voted to defer action on
the petition to allow staff to conduct further research.\3\ On July 26,
2023, staff submitted an updated briefing package to the Commission
regarding the petition.\4\ The Commission granted the petition on
August 1, 2023, directing staff to initiate rulemaking to address the
inhalation hazard associated with aerosol duster products.\5\
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\2\ <a href="http://www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard_0.pdf?VersionId=GNEl7pYZUBOxf1BLSC0f4.X6TlA8gT4f">www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard_0.pdf?VersionId=GNEl7pYZUBOxf1BLSC0f4.X6TlA8gT4f</a>.
\3\ <a href="http://www.cpsc.gov/s3fs-public/RCA-Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Dusters-Products-Petition-CP-21-1.pdf?VersionId=uD1mraIGCZcjBd9xiyZsanVRbngVzUvP">www.cpsc.gov/s3fs-public/RCA-Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Dusters-Products-Petition-CP-21-1.pdf?VersionId=uD1mraIGCZcjBd9xiyZsanVRbngVzUvP</a>.
\4\ <a href="http://www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?VersionId=.NohA6DG6WsXh_tsjhGuA7RuqMCOvxSW">www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?VersionId=.NohA6DG6WsXh_tsjhGuA7RuqMCOvxSW</a>.
\5\ <a href="http://www.cpsc.gov/s3fs-public/RCAPetitionRequestingRulemakingtoEstablishSafetyStandardforAerosolDusterProductsPetitionCP21_1.pdf?VersionId=nQcgEM4wvCJE97zmhwYCdAkwuluYerIt">www.cpsc.gov/s3fs-public/RCAPetitionRequestingRulemakingtoEstablishSafetyStandardforAerosolDusterProductsPetitionCP21_1.pdf?VersionId=nQcgEM4wvCJE97zmhwYCdAkwuluYerIt</a>.
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II. Statutory Authority
This rulemaking is conducted under the provisions of the FHSA and
the Consumer Product Safety Act (CPSA). 15 U.S.C. 1261-1278; 15 U.S.C.
2058. The rulemaking proposal involves two elements. First, pursuant to
sections 2(f)(1)(A), 2(q)(1)(B), and 3 of the FHSA, the Commission is
proposing to ban any aerosol duster product containing more than 18 mg
of either of two hydrofluorocarbon propellants--1,1-difluoroethane
(HFC-152a, CAS # 75-37-6) and 1,1,1,2-tetrafluoroethane (HFC-134a, CAS
# 811-97-2)--or of a combination of these propellants. 15 U.S.C.
1261(f)(1)(A), (q)(1)(B), 1262 (proposed 16 CFR 1500.17(a)(14)).
Second, to prevent circumvention of the proposed ban, pursuant to
section 9(g)(2) of the CPSA, the Commission is proposing a stockpiling
prohibition that would prohibit a manufacturer from stockpiling banned
aerosol duster products containing above the specified amount of HFC-
152a and/or HFC-134a that are subject to the proposed ban. 15 U.S.C.
2058(g)(2).
More specifically, the Commission is proposing to declare that any
aerosol duster canister containing more than 18 mg of HFC-152a and/or
HFC-134a to be a ``hazardous substance'' and a ``banned hazardous
substance'' within the meaning of sections 2(f)(1)(A) and
[[Page 61365]]
(q)(1)(B) of the FHSA.\6\ 15 U.S.C. 1261(f)(1)(A), (q)(1)(B). Section
2(q)(1)(B) of the FHSA defines a ``banned hazardous substance'' to
include any hazardous substance intended, or packaged in a form
suitable, for household use which, notwithstanding the precautionary
labeling required by the FHSA, presents such a hazard that keeping the
substance out of interstate commerce is the only adequate means to
protect the public health and safety. 15 U.S.C. 1261(q)(1)(B).
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\6\ The Commission voted 5-0 to publish this proposed rule.
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A proceeding to classify a hazardous substance as a ``banned
hazardous substance'' under section 2(q)(1)(B) of the FHSA is governed
by the requirements set forth in section 3 of the FHSA. See 15 U.S.C.
1261(q)(2) and 1262. The proposed rule begins the rulemaking process in
accordance with the requirements of sections 3(a) and (h) of the FHSA.
See 15 U.S.C. 1262(a) and (h). Pursuant to section 3(a), the Commission
is proposing to declare any aerosol duster canister containing more
than 18 mg in any combination of HFC-152a and/or HFC-134a to be a
hazardous substance. In order to declare that a hazardous substance is
banned, section 3(h) of the FHSA requires the Commission to publish in
the Federal Register the text of a proposed rule, including any
alternatives together with a preliminary regulatory analysis
containing: (1) a preliminary description of the potential benefits and
costs of the proposed rule; (2) a discussion of the reasons why any
standard or portion of a standard submitted to the Commission was not
published as the proposed rule; (3) a preliminary determination
regarding why the voluntary standards process would not, within a
reasonable time, result in the development of a voluntary standard that
would eliminate or adequately reduce the risk of injury identified in
the rule; and (4) a description of any reasonable alternatives to the
proposed rule, together with a summary description of the potential
benefits and costs, and a brief explanation of why such alternatives
should not be published as the proposed rule. 15 U.S.C. 1262(h).
Before issuing a final rule banning any hazardous substance, the
Commission must publish the text of the final rule and a final
regulatory analysis that includes: (1) a description of the potential
benefits and costs of the rule (including costs and benefits that
cannot be quantified in monetary terms, and identification of those
likely to receive the benefits and bear the costs); (2) a description
of alternatives considered by the Commission (including a description
of their potential benefits and costs and an explanation of why the
alternatives were not chosen); and (3) a summary of significant issues
raised by comments on the preliminary regulatory analysis and a summary
of the assessment by the Commission of such issues. 15 U.S.C.
1262(i)(1). The Commission must also make findings that: (1) any
relevant voluntary standard is unlikely to adequately reduce the risk
of injury or substantial compliance with the voluntary standard is
unlikely; (2) the expected benefits of the regulation bear a reasonable
relationship to expected costs; and (3) the regulation imposes the
least burdensome requirement that would adequately reduce the risk of
injury. 15 U.S.C. 1262(i)(2).
III. The Product
A. Description of the Product
Aerosol duster products use a trigger or similar means to release a
propellant \7\ (typically a hydrofluorocarbon) through an orifice or
attachment such as a nozzle or straw for the purpose of blowing and
removing dust and debris from hard-to-reach places. Although sometimes
referred to as ``canned air,'' aerosol duster products actually contain
essentially 100 percent propellent,\8\ which is typically a chemical
such as a hydrofluorocarbon that can be compressed into a liquid for
storage. Each such aerosol duster canister typically contains about 3
to 20 ounces (85 g to 567 g) of compressed liquid in equilibrium with a
small amount of evaporated gas or vapor of that same chemical. The gas
or vapor, consisting of nearly pure propellant chemical, is expelled
when the trigger or similar means is activated, which causes more of
the liquid to evaporate into gas or vapor within the canister in order
to return to equilibrium. This allows multiple uses per canister.
Figure 1 below, from US Patent, US-9234123-B2 \9\ illustrates an
example of an aerosol duster product showing the propellent liquid and
vapor existing in equilibrium.
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\7\ Aerosol propellant is a liquid which exists in equilibrium
also as a gas, or compressed gas that is used to expel aerosol
content from a pressurized container.
\8\ Various aerosol duster products include trace amounts of
denatonium benzoate, or other bitterants in order to discourage
inhalant abuse.
\9\ <a href="https://patentcenter.uspto.gov/applications/13848372">https://patentcenter.uspto.gov/applications/13848372</a>.
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[[Page 61366]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.628
Aerosol duster products are sold under a variety of brand names and
are available in various brick and mortar stores and online retail
locations. They are relatively inexpensive to purchase and easy to
obtain either in stores or online. For example, online retailers sell
individual canisters for about $8-10 per canister, and some retailers
offer a discount when the product is purchased in bulk. Aerosol duster
products are often referred to as electronics dusters, computer
keyboard cleaners, canned air or compressed air dusters, aerosol cans
or spray, and electronics air cleaners, among other names. (See Figure
2 below for examples of 10 oz aerosol duster products).
[GRAPHIC] [TIFF OMITTED] TP31JY24.629
Aerosol duster products typically use one or more of three
propellants: 1,1-difluorethane (HFC-152a, CAS #75-37-6), 1,1,1,2-
tetrafluoroethane (HFC-134a, CAS #811-97-2), and/or trans-1,3,3,3-
tetrafluoropropene (HFO-1234ze, CAS
[[Page 61367]]
#29118-24-9). HFC-152a and HFC-134a are known to be hazardous as
explained in this Notice. According to Euromonitor, approximately 87
percent of aerosol duster products available for sale in the U.S. use
the propellant HFC-152a and 11 percent use HFC-134a. HFO-1234ze is a
new propellant. The abuse potential for HFO-1234ze is unknown due to
its relatively low use in consumer applications. Similarly, other
effects on humans have not been reported. Further discussion about HFO-
1234ze can be found in Tab B of the July 2023 staff petition briefing
package.\10\
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\10\ <a href="http://www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?VersionId=.NohA6DG6WsXh_tsjhGuA7RuqMCOvxSW">www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?VersionId=.NohA6DG6WsXh_tsjhGuA7RuqMCOvxSW</a>.
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In order to determine the amount of propellant released from a
single use of an aerosol duster product, laboratory sciences staff
conducted testing of various aerosol duster products,\11\ and based on
that testing, determined that a trigger pull from a single aerosol
duster canister lasting 5 seconds \12\ releases 7.53 grams of
propellant, when not using the straw provided with the product. This
information regarding the 5 second time per trigger pull helped staff
better understand how much propellant inhalant abusers are able to
inhale with a single trigger pull of an aerosol duster product.
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\11\ <a href="http://www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?VersionId=.NohA6DG6WsXh_tsjhGuA7RuqMCOvxSW">www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?VersionId=.NohA6DG6WsXh_tsjhGuA7RuqMCOvxSW</a>, July 26, 2023,
Table 9, Page 27.
\12\ A trigger pull lasting 5 seconds was chosen based on online
video research which found users inhaling aerosol dusters without
any straw attachment for that length of time: <a href="https://youtu.be/FjlazUNE2-8?si=WsA4nfSbLX_jJ2SR&t=40">https://youtu.be/FjlazUNE2-8?si=WsA4nfSbLX_jJ2SR&t=40</a>. This reference video shows
that the euphoric/high effects appear to occur with a single trigger
pull of five seconds.
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B. Scope of Products Subject to the NPR
Aerosol duster products are generally intended to be used for
cleaning and blowing off dust from electronics as well as other
household items. This NPR would apply only to aerosol duster products
that contain the propellants HFC-152a or HFC-134a. Aerosol duster
products using HFO-1234ze (or other substances) as a propellant are
outside the scope of this NPR. Other examples of aerosol products that
are outside the scope of this NPR include products that use HFC-152a or
HFC-134a as propellants in freeze sprays used to cool circuit boards,
automotive refrigerants, and medical freeze sprays used to cool tissue
specimens as well as aerosol products that use HFC-152a or HFC-134a as
propellants but include substantial additional components (such as air
fresheners, paints, lubrication oils, body sprays, and silicone
lubricant sprays for food pans).
C. Alternatives to Aerosol Duster Products With HFC-152a and HFC-134a
Alternatives to aerosol duster products are currently being sold
for the same purpose as aerosol duster products. For example,
alternatives include compressed air dusters which use corded or
cordless electric pumps, or hand pumps that compress air and blow and/
or vacuum it through a nozzle to remove dirt and debris. According to
data collected in 2023, the average price of an electric duster is
approximately $56, similar to the price of seven disposable aerosol
duster canisters.\13\ Staff tested battery operated USB rechargeable
duster devices. The goal was to compare air speeds, measured in meters/
second (m/s), generated by the battery powered devices to the speeds
generated by an aerosol duster product. Three battery powered devices
and two name-brand aerosol dusters were chosen for the comparison.
Staff concluded that battery powered air duster devices generate
comparable air speeds to the propellant speeds of aerosol duster
products. See Tab D of the July 26, 2023, staff briefing package for
more details on electronic dusters.\14\ Carbon dioxide (CO<INF>2</INF>)
cartridge dusters that use disposable CO<INF>2</INF> cartridges to blow
CO<INF>2</INF> through a nozzle to remove dirt and debris are available
as well. Consumers can also use vacuum cleaners to remove dust. Thus, a
number of alternative products exist that provide similar utility to
that provided by aerosol duster products.
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\13\ Aerosol Duster Supporting Database, August 2023. (<a href="https://www.cpsc.gov/content/Aerosol-Duster-Supporting-Database">https://www.cpsc.gov/content/Aerosol-Duster-Supporting-Database</a>).
\14\ <a href="http://www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?VersionId=.NohA6DG6WsXh_tsjhGuA7RuqMCOvxSW">www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?VersionId=.NohA6DG6WsXh_tsjhGuA7RuqMCOvxSW</a>.
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IV. Description of the Hazard
Aerosol duster products can cause significant toxicity or death if
used as inhalants (Williams, 2007). Inhalants are volatile substances
that produce chemical vapors that can be inhaled to induce
psychoactive, or mind-altering, effects.\15\ The inhalants in aerosol
duster products are legally sold for purposes other than use as
inhalants, are widely available, and are inexpensive. Inhalant abusers
include males and females ranging in age from teenagers to adults in
their 60s. Approximately 10 to 50 percent of cases of inhalant abuse
may lead to abuse or dependance, depending on the characteristics of
the population studied (Perron et al., 2021).
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\15\ See <a href="http://nida.nih.gov/publications/research-reports/inhalants/what-are-inhalants">nida.nih.gov/publications/research-reports/inhalants/what-are-inhalants</a>.
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Staff has identified two toxic substances, HFC-152a and HFC-134a,
that are commonly used as propellants in aerosol duster products and
are widely used for inhalant abuse. Inhalant abusers use propellants to
get ``high'' (Koehler and Henninger, 2014). These propellants can be
sniffed, snorted or sprayed,\16\ huffed,\17\ or bagged \18\ as
inhalants to obtain a rapid euphoric effect (DEA, 2020). The euphoric
effect only lasts a few minutes, requiring the repeat use of an aerosol
duster product every few minutes to maintain the euphoria. These
propellants can damage the heart when abused, making an individual more
susceptible to a heart attack or arrhythmia \19\ after an individual
inhales the propellant. The abuse potential of the propellants HFC-152a
and HFC-134a are further discussed below.
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\16\ Inhaling or spraying refers to inhaling the substance into
the nose or mouth directly from the container.
\17\ Huffing refers to placing a bag saturated with a substance
over the mouth and using the nose or mouth to inhale the
concentrated fumes.
\18\ Bagging refers to concentrating an aerosol in a bag before
inhaling.
\19\ A heart arrhythmia is an irregular heartbeat caused by
electrical problems in the heart.
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A. Inhalants Used in Aerosol Duster Products
1. HFC-152a (1,1-difluorethane)
HFC-152a is widely used as a propellant in the aerosol duster
product market.\20\ HFC-152a works through specific brain receptors
\21\ such as glutamate/N-methyl-D-aspartate (NMDA),\22\ gamma-
aminobutyric acid (GABA),\23\ and dopamine \24\ to elicit euphoria
(Duncan and Lawrence, 2013). Aerosol duster products, especially those
containing HFC-152a, are the ``drug of choice'' for many who use
inhalants because they are easy to obtain, inexpensive, and contain 100
percent HFC-152a without any additional components such as paint or air
freshener in the propellant (Beauvais and Oetting, 1987). After
inhalation of
[[Page 61368]]
such a lipophilic \25\ propellant, the substance is rapidly absorbed
into the pulmonary vasculature, going directly into the lungs and
easily crossing the blood-brain barrier into the brain to exert its
euphoric effects. The onset of HFC-152a intoxication is rapid, and the
intoxication effects are brief and dose-related, ranging from euphoria,
decreased inhibition, motor excitation, and light-headedness (Koehler
and Henninger, 2014).
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\20\ According to Euromonitor, approximately 87 percent of
aerosol duster products available for sale in the U.S. use the
propellant HFC-152a and 11 percent use HFC-134a.
\21\ Proteins that serve as a sensor for a particulate type of
molecules.
\22\ The NMDA receptors are a class of receptors that respond to
the neurotransmitter N-methyl-D-aspartate.
\23\ The GABA receptors are a class of receptors that respond to
the neurotransmitter gamma-aminobutyric acid.
\24\ Dopamine is a brain neurotransmitter.
\25\ Lipophilic means the tendency to combine with fats.
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Toxicity in humans can occur after an acute or chronic exposure to
HFC-152a (Poisindex, 2021). Severe HFC-152a toxicity can cause a
depressed mental state, respiratory depression, pulmonary edema,
hepatic injury, and death (Poisindex, 2021). Death can occur due to
sudden sniffing death syndrome (SSDS), which was first described in
1970 (Bass, 1970; George et al., 2021). Individuals inhale fluorinated
hydrocarbons to become ``high'' and, if physical exertion or stress
occurs, the inhaler may collapse and die. (Smeeton and Clark, 1985;
Kamm, 1975; Dingle and Williams, 2019; Poisindex, 2021). Predicting the
toxicity of inhaling a certain number of aerosol duster canisters is
difficult because there is no clear dose-response evident in the
medical literature. Death from abusing aerosol duster products is not
dose dependent.\26\ The medical literature indicates the use of only
one canister has resulted in death (Xiong et al., 2004), while in
another case inhaling multiple canisters over several years did not
cause death (Peicher and Maalofouf, 2017). However, abrupt cessation of
HFC-152a abuse can induce withdrawal \27\ with tremors, excessive
sweating, nausea, vomiting, depression, anxiety, irritability,
psychosis, and hallucinations (Custer et al., 2020).
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\26\ If the effect is changing with the dose of the drug it is
described as dose dependent.
\27\ Psychotic symptoms associated with drug cessation.
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2. HFC-134a (1,1,1,2-tetrafluoroethane)
HFC-134a is another substance used as a propellant in aerosol
duster products. HFC-134a is a member of the anesthetic drug class \28\
(Shah et al., 2015). HFC-152a and HFC-134a have different binding
mechanisms.\29\ It is unclear whether the same addictive properties of
HFC-152a translate to HFC-134a, but data from CPSC's Consumer Product
Safety Risk Management System (CPSRMS) discussed below, show that
multiple individuals have died after inhaling HFC-134a. Two other
papers from medical literature demonstrate that acute exposure of HFC-
134a from inhalation can be harmful (Romero et al., 2022; Burke et al.,
2020). Several papers have indicated that inhalation with acute
exposure to HFC-134a in humans has resulted in reactive airway
dysfunction syndrome,\30\ (Doshsti et al., 2016), severe hypotension,
loss of consciousness, shock (Vinegar, 1997), cardiac sensitization,
neurotoxicity (National Research Council, 2002), and death (Burke et al
et al., 2020).
---------------------------------------------------------------------------
\28\ Substance that induces insensitivity to pain.
\29\ Binding of a substance to a receptor molecule changes its
shape or activity to transmit a signal.
\30\ Breathing symptoms similar to asthma but with an uncertain
cause.
---------------------------------------------------------------------------
B. Description of the Hazard Pattern
To examine the hazard pattern for inhalation abuse of aerosol
duster products, staff conducted 23 in-depth investigations (IDIs) with
family members of individuals who died from inhaling aerosol duster
products during 2020 and 2021. These IDIs were all related to HFC-152a
abuse and included nine females and 14 males, between the ages of 15 to
61 years-old.
The review of the IDIs indicated the number of canisters found at
the scene, the victim's history of abuse, and the scene of the
incident. In five IDIs \31\ only one empty canister was identified,
though in some of these IDIs multiple full cans were found at the
scene, and the victim had a history of aerosol duster abuse. In twelve
incidents,\32\ the IDIs reported that more than one completely or
partially empty canister was found at the victim's death scene. In
several IDIs,\33\ twenty or more canisters of aerosol duster product
were found with the victim at the death scene. The majority of the
victims died at home, while some were found deceased in motels or in
parked vehicles.
---------------------------------------------------------------------------
\31\ IDI numbers 230406HCC1189, 230815HCC1044, 230822HCC1098,
230906HCC1211, 231005HCC3036.
\32\ IDI numbers 23071HCC3850, 230329HCC1057, 230707HCC1701,
230720HCC1777, 230725HCC1827, 230808HCC3987, 230822HCC1099,
230906HCC1208, 230906HCC1209, 230929HCC1377, 230329HCC1048,
230711HCC1721.
\33\ IDI numbers 230711HCC3850, 230329HCC1057, 230707HCC1701,
230711HCC1721, 230720HCC1777, 230725HCC1827, 230808HCC3987,
230822HCC1099, 230906HCC1208, 230906HCC1209, 230929HCC1377,
230929HCC1048.
---------------------------------------------------------------------------
Based upon staff's review of 23 IDIs and available medical
literature, the hazard pattern for inhalation deaths from HFC-152a
aerosol duster products includes both males and females; covers a wide
age range; indicates that death can occur from inhalation of a single
canister or multiple canisters; and shows that most victims died at
home, but deaths also occurred in motels and parked vehicles. As stated
above, the hazard pattern for HFC-134a is believed to be similar to the
hazard pattern for HFC-152a because both propellants are inhalational
anesthetics with similar toxicities at high doses.
C. Incident Data
1. Deaths
This section presents information on fatal incidents reported to
CPSC that involved inhalation abuse (commonly known as sniffing,
spraying or huffing, but referred to here as inhaling or inhalation) of
aerosol duster products. The most recent search of the CPSC databases
for incidents involving inhalation abuse of aerosol duster products was
conducted in February 2024.
CPSC databases (CPSRMS and the National Electronic Injury
Surveillance System (NEISS)) do not contain a specific product code for
aerosol duster products. Accordingly, the product codes searched in
CPSRMS at that time were 1133 (Aerosol containers), 921 (Chemicals not
elsewhere classified), and 954 (General-purpose household cleaners).
Aerosol duster products are included as a sub-category of product code
954 but may occasionally be sorted into product codes 1133 and 921.
Aerosol duster products were identified in CPSRMS incident narratives
or product descriptions as dusters, aerosol dusters, computer/keyboard/
electronics dusters or cleaners, canned/compressed air, or by specific
brand names, including misspelled variants of the above keywords. This
review excluded aerosol duster incidents that were exclusively
associated with common non-inhalation hazards from aerosol duster
products, such as explosions, fires, chemical burns, or respiratory
injuries related to the product's intended use.
CPSC's CPSRMS database contains reports for 1,039 unique fatal
incidents involving inhalation hazards from aerosol duster products
that occurred between January 1, 2012, and December 31, 2021. Data
collection is ongoing in CPSRMS and reporting is considered incomplete
for more recent years (2022-2024). The number of deaths associated with
aerosol duster products reflected in CPSRMS and classified as involving
aerosol duster inhalation is almost certainly an underestimate of the
actual number of aerosol duster inhalation deaths.
Almost all of the 1,039 deaths were reported from death
certificates and
[[Page 61369]]
Medical Examiners and Coroners Alert Project (MECAP) reports. Among
these 1,039 deaths, 775 (75%) were attributed to HFC-152a toxicity, and
three were attributed to HFC-134a toxicity. In the remaining incident
reports, the specific aerosol duster propellant is not explicitly
identified. For several of the deaths that occurred in 2020 and 2021,
staff conducted IDIs to learn more about the details surrounding the
fatal incident (i.e., victim's history of using aerosol duster
products). This death count only includes incidents where the product
involved was explicitly identified as an aerosol duster product.
Deaths from HFC-152a toxicity where the specific product was not
identifiable, and deaths resulting from the inhalation of unspecified
aerosols, are not included in the figures given above. Although HFC-
152a is commonly used as a propellant in aerosol duster products, the
compound is also used in other aerosol products, such as pesticides and
air fresheners. Between 2012-2021, there were an additional 1,031
deaths reported in CPSRMS resulting from HFC-152a toxicity from an
unspecified aerosol product. The age, gender, and race/ethnicity
distributions of these deaths are similar to those for the aerosol
duster product inhalation deaths discussed in this section.
Additionally, between 2012-2021, there were at least 63 deaths found in
CPSRMS that mentioned inhalation of aerosol products, without giving
sufficient information to determine if the product was an aerosol
duster product. Because the scope of the data analyses here only
includes incidents explicitly mentioning an aerosol duster product,
these deaths are not included among the 1,039 fatal incidents in the
analyses discussed above.
CPSC is aware of at least seven deaths resulting from HFC-134a
toxicity between 2012 and 2021. In three of these deaths, the product
involved was identified as an aerosol duster product, and these three
deaths are included in the above aerosol duster products fatality
count. The remaining four deaths either did not specify the type of
product involved, or they involved an unspecified aerosol product. CPSC
has also received reports of deaths involving HFC-134a toxicity that
occurred between 2006 and 2010, including some that specifically
identified an aerosol duster product being involved.
Table 1 below provides an overview of the distribution of aerosol
duster inhalation deaths found in CPSRMS, which, as noted, almost
certainly understates the actual number of deaths reported to CPSC from
these products. Data in CPSRMS are anecdotal in nature and do not
necessarily represent all incidents that have actually occurred.
Furthermore, death certificates tend to have a greater lag time between
the incident/death date and the date the death was reported to CPSC.
Therefore, the counts below are subject to increase, especially for the
more recent years.
Table 1--Aerosol Duster Inhalation Deaths by Year
[2012-2021]
------------------------------------------------------------------------
Year Total deaths
------------------------------------------------------------------------
2012.................................................... 54
2013.................................................... 104
2014.................................................... 90
2015.................................................... 124
2016.................................................... 130
2017.................................................... 127
2018.................................................... 124
2019.................................................... 114
2020.................................................... 89
2021.................................................... 83
---------------
Total............................................... 1,039
------------------------------------------------------------------------
Source: CPSRMS.
Percentages may not add to 100% due to rounding.
Table 2 below provides an overview of the distributions of aerosol
duster product inhalation deaths by age group and gender. Among the
identified deaths, almost 70 percent were male, and 94 percent were
between the ages of 18 and 54, with ages ranging between 13 and 70
years old.
Table 2--Distribution of Aerosol Duster Inhalation Victims by Age Group and Gender
[2012-2021]
----------------------------------------------------------------------------------------------------------------
Age group (years) Male Female Total
----------------------------------------------------------------------------------------------------------------
0-17 *.......................................................... 4 8 12 (1%)
18-34........................................................... 296 159 455 (44%)
35-54........................................................... 376 143 519 (50%)
55 or older..................................................... 40 12 52 (5%)
Unspecified..................................................... 1 0 1 (<1%)
-----------------------------------------------
Total....................................................... 717 (69%) 322 (31%) 1,039
----------------------------------------------------------------------------------------------------------------
Source: CPSRMS.
Percentages may not add to 100% due to rounding.
Race information was reported in 881 (85%) of the 1,039 deaths.
Table 3 provides an overview of the distribution of aerosol duster
inhalation deaths by race where the data were available. Over 92
percent of the victims were white.
Table 3--Distribution of Aerosol Duster Inhalation Deaths by Race
[2012-2021]
------------------------------------------------------------------------
Race Total Percent
------------------------------------------------------------------------
White................................... 814 92
Black/African-American.................. 24 3
American Indian/Alaska Native........... 17 2
Other *................................. 26 3
-------------------------------
Total............................... 881 100
------------------------------------------------------------------------
Source: CPSRMS.
* Includes Asian, Native Hawaiian/Pacific Islander and Other race
categories.
[[Page 61370]]
Ethnicity data for aerosol duster inhalation deaths between 2012
and 2021 are also incomplete. The ethnicity is known for 769 (74%) of
the 1,039 deaths. Among the 769 deaths with known ethnicity, 56 (7%)
were identified as Hispanic, while 713 (93%) were identified as non-
Hispanic.
Table 4 below provides an overview of the distribution of aerosol
duster inhalation deaths found in CPSRMS by the incident location of
the death. Location information was specified for 891 (88%) of the
1,039 deaths. Most of the deaths (78%) occurred in a housing unit,
apartment, or condominium.
Table 4--Distribution of Aerosol Duster Inhalation Deaths
by Incident Location [2012-2021]
------------------------------------------------------------------------
Location Total Percent
------------------------------------------------------------------------
Home/Apartment/Condominium *............ 711 78
Other Public Property/Office............ 128 14
Street/Highway.......................... 8 1
Place of Recreation or Sports........... 5 1
Other **................................ 63 7
-------------------------------
Total............................... 915 100
------------------------------------------------------------------------
Source: CPSRMS.
Percentages may not add to 100% due to rounding.
* Includes mobile and manufactured homes.
** Includes a school, industrial location or any other location.
Table 5 and Figure 3 provide an overview of the distribution of
aerosol duster product inhalation deaths in CPSRMS by U.S. state. The
states with the most reported aerosol duster inhalation deaths are
Florida (83), Texas (67), California (67), Georgia (58) and North
Carolina (47). Over 30 percent of all aerosol duster inhalation deaths
reported to CPSC occurred in these five states.
Table 5--Number of Reported Fatal Duster Incidents by State
[2012-2021]
----------------------------------------------------------------------------------------------------------------
State Deaths State Deaths
----------------------------------------------------------------------------------------------------------------
Florida....................................... 83 Arizona......................... 11
California.................................... 67 Nebraska........................ 11
Texas......................................... 67 Maryland........................ 10
Georgia....................................... 58 Montana......................... 10
North Carolina................................ 47 Massachusetts................... 9
Illinois...................................... 46 South Dakota.................... 9
New Mexico.................................... 40 Nevada.......................... 8
Oregon........................................ 37 Oklahoma........................ 8
Minnesota..................................... 36 Kansas.......................... 7
Colorado...................................... 35 Delaware........................ 6
Missouri...................................... 33 Mississippi..................... 6
Michigan...................................... 30 North Dakota.................... 6
Ohio.......................................... 30 Wyoming......................... 6
Arkansas...................................... 29 Alaska.......................... 5
Pennsylvania.................................. 28 New Jersey...................... 5
Tennessee..................................... 28 Idaho........................... 4
Virginia...................................... 28 Maine........................... 4
Indiana....................................... 27 New Hampshire................... 4
New York...................................... 25 Connecticut..................... 3
Iowa.......................................... 21 Hawaii.......................... 3
Washington.................................... 20 Rhode Island.................... 3
Wisconsin..................................... 20 Vermont......................... 3
Louisiana..................................... 18 Utah............................ 2
South Carolina................................ 17 West Virginia................... * 0
Alabama....................................... 13 D.C............................. * 0
---------------
Kentucky...................................... 13 Total........................ 1,039
----------------------------------------------------------------------------------------------------------------
Source: CPSRMS.
* CPSC did not receive any reports related to deaths due to aerosol duster inhalation from West Virginia or the
District of Columbia that occurred between 2012 and 2021.
[[Page 61371]]
[GRAPHIC] [TIFF OMITTED] TP31JY24.630
2. Injury Estimates
This section presents information on emergency department treated
injuries resulting from inhalation abuse of aerosol duster products.
The estimates are derived from injury cases that were recorded in
CPSC's NEISS database,\34\ and the injuries were treated during the 10-
year period between January 1, 2012, and December 31, 2021. Between
2012-2021, it is estimated that there were 21,700 ED-treated injuries
in the United States resulting from inhalation of aerosol duster
products. This estimate is based on a sample of 491 NEISS-reported
injury cases, three of which were deaths. These three deaths are
included among the 1,039 deaths from CPSRMS that are discussed above.
---------------------------------------------------------------------------
\34\ More information about the NEISS sample and estimate
calculation can be found here: Explanation Of NEISS Estimates
Obtained Through The CPSC website [verbar] <a href="http://CPSC.gov">CPSC.gov</a>.
---------------------------------------------------------------------------
Injury incident cases were included in the sample only if the
product being used could reasonably be classified as an aerosol duster
product. While CPSRMS incidents typically report product identifying
characteristics (i.e., manufacturer, brand, model, retailer, product
description), NEISS injury narratives rarely provide such detailed
information on the products involved. Thus, NEISS data are likely an
underestimate of the true number of ED-treated injuries, as more
generic product classifications (i.e., cleaning product, household
cleaner, etc.) may be used to describe aerosol duster products. An
additional 2,500 estimated ED-treated injuries resulted from
``huffing'' unspecified products, or inhalation of products described
as ``aerosol cans,'' ``aerosol cleaners,'' or simply ``aerosols,'' but
these injuries are excluded from this analysis because of the non-
specificity of the product description and the lack of information on
the propellant being inhaled. Other types of injuries not involving
aerosol duster inhalation, such as respiratory injuries from the
product being sprayed, are not included in the above estimates.
Table 6 below presents yearly estimates of ED-treated injuries in
the United States from inhaling aerosol duster products. Between 2012-
2021, there is no evidence of a statistically significant linear trend
in ED-treated injuries due to aerosol duster inhalation (p-value
>0.05).
Table 6--NEISS Estimates for Aerosol Duster Inhalation Injuries by Year
[2012-2021]
----------------------------------------------------------------------------------------------------------------
Year Estimate \35\ Sample size CV
----------------------------------------------------------------------------------------------------------------
2012............................................................ ** 23 .28
2013............................................................ 2,000 46 .22
2014............................................................ 1,500 35 .28
2015............................................................ 2,500 45 .26
2016............................................................ 3,000 66 .28
[[Page 61372]]
2017............................................................ 2,700 67 .22
2018............................................................ 2,100 53 .21
2019............................................................ 2,000 50 .30
2020............................................................ ** 56 .38
2021............................................................ 2,000 50 .27
-----------------------------------------------
2012-2021................................................... 21,700 491 .18
----------------------------------------------------------------------------------------------------------------
Source: NEISS.
Estimates rounded to nearest 100; estimates that failed to meet NEISS publication criteria are presented as **.
Rows may not add to total due to rounding.
Table 7 below depicts a breakdown of the disposition of the injured
patients. A large majority (70%) of the estimated injuries were
categorized as ``treated and released'' or ``examined and released
without treatment,'' while around 20 percent involved more serious
injuries requiring hospitalization or additional observation.
---------------------------------------------------------------------------
\35\ According to the NEISS publication criteria, an estimate
can only be presented if it is 1,200 or greater, is derived from a
sample size of at least 20 injury cases and has a coefficient of
variation (CV) no greater than 33 percent. As such, estimates that
do not meet all three of the above criteria are not presented in any
table. CV is calculated by dividing an estimate's standard deviation
by the estimate itself.
Table 7--NEISS Estimates for Aerosol Duster Inhalation Injuries by
Disposition
------------------------------------------------------------------------
Disposition Estimate Sample size
------------------------------------------------------------------------
Treated and released, or Examined and 15,200 (70%) 341
released without treatment.............
Treated and admitted for 4,400 (20%) 103
hospitalization, or Held for
observation............................
Left without being seen, or Left without 1,900 (9%) 44
treatment..............................
Death *................................. ** (<1%) 3
-------------------------------
All Severities...................... 21,700 491
------------------------------------------------------------------------
Source: NEISS.* Fatal injury cases in NEISS are also included in CPSRMS
data and are thus included in the overall death count.
Estimates rounded to nearest 100; estimates that failed to meet NEISS
publication criteria are presented as **.
Rows may not add to total due to rounding.
Table 8 below depicts an overview of the injuries based on age and
gender. Around two-thirds of the estimated injuries occurred in males,
and around 91 percent of estimated injuries occurred in patients
between ages 18 and 54.
Table 8--NEISS Estimates for Aerosol Duster Inhalation Injuries by Age & Gender
----------------------------------------------------------------------------------------------------------------
Age group (years) Male Female Total
----------------------------------------------------------------------------------------------------------------
0-17........................................................... ** ** 1,500 (7%)
18-34.......................................................... 6,800 3,300 10,100 (47%)
35-54.......................................................... 6,200 3,400 9,600 (44%)
55 or older.................................................... ** ** ** (2%)
------------------------------------------------
Total...................................................... 14,300 (65%) 7,500 (35%) 21,700 (100%)
----------------------------------------------------------------------------------------------------------------
Source: NEISS.
Estimates rounded to nearest 100; estimates that failed to meet NEISS publication criteria are presented as **.
Estimates and percents may not add to the total due to rounding.
Race and ethnicity data are largely incomplete for aerosol duster
product inhalation injury cases between 2012-2021. Race is unknown for
around 37 percent of the 21,700 ED-treated injuries during the 10-year
period. Among the 13,700 injuries where race is known, white
individuals constituted around 83 percent of injuries; Black
individuals constituted 6 percent of injuries; and other races
constituted the remaining 11 percent. Ethnicity data was added to the
NEISS database starting in mid-2018. As such, ethnicity is unknown for
the majority (79%) of injuries reported during the period reviewed.
Among the 4,500 injuries with known ethnicity, Hispanic individuals
constituted 37 percent of injuries, while non-Hispanic individuals
constituted the remaining 63 percent.
Approximately 5,700 of the estimated 21,700 ED-treated injuries
(26%) occurred at home. Another 6,300 estimated injuries (29%) took
place on public property, and 2,200 estimated injuries (10%) took place
on a street or highway, at a school, or at a place of recreation. The
location for the remaining 7,600 estimated injuries (35%) was either
unknown or not recorded.
[[Page 61373]]
Approximately 18,700 of the estimated 21,700 ED-treated injuries
(86%) were diagnosed primarily as poisonings, while the remaining 3,000
estimated injuries were diagnosed mostly as burns (chemical, thermal or
unspecified), anoxia, contusions/abrasions, lacerations, or internal
organ injuries. Approximately 18,900 of the estimated 21,700 ED-treated
injuries (87%) were considered ``whole body'' injuries (i.e., no
specific individual body part injured as a result of inhalation).
Another 1,700 estimated injuries (8%) were classified as head, face, or
mouth injuries, while the remaining 5 percent of injuries were mostly
classified as hand, lower arm, or upper trunk injuries.
D. Availability of Incident Data
Upon publication of the NPR in the Federal Register, CPSC will make
available for review and comment, to the extent allowed by law, the
CPSRMS and NEISS incident reports relied upon and discussed in the NPR,
along with the associated IDIs. The data can be obtained by submitting
a request to: <a href="https://forms.office.com/g/NK9WAGMhAi">https://forms.office.com/g/NK9WAGMhAi</a>. You will then
receive a website link to access the data at the email address you
provided. If you do not receive a link within 72 hours, please contact:
<a href="/cdn-cgi/l/email-protection#6f0c1c0c001d1f06002f0c1f1c0c41080019"><span class="__cf_email__" data-cfemail="442737272b36342d2b04273437276a232b32">[email protected]</span></a>.
V. Absence of Relevant Voluntary Standard
Two existing voluntary standards, ASTM D3061-97, Standard Guide for
Three-Piece Steel and Tinplate Straight-Wall and Necked-In Aerosol
Cans, and DIN EN 15008:2017, Aerosol Containers--Aluminum Containers--
Dimensions of One-Piece Cans with 25.4 mm Aperture, apply to aerosol
duster products. Both standards provide a list of currently
manufactured aerosol canister sizes as well as industry voluntary
dimensional guidelines, but neither standard addresses the hazard of
intentional inhalant abuse.
On February 27, 2023, ASTM Committee F15 hosted an exploratory
meeting discussing potential solutions that would prevent intentional
inhalation and abuse of aerosol duster products such as including
bitterants, warning labels, and use of alternative propellants and
alternative technologies. On March 4, 2024, ASTM Committee F15 hosted a
second exploratory meeting to discuss developing a possible future
voluntary standard and forming a task group for the prevention of
intentional inhalation and abuse of aerosol duster products. To date no
such task group has been formed.
VI. Justification for the Proposed Ban
The FHSA defines a hazardous substance to include a substance that
is ``toxic.'' 15 U.S.C. 1261(f)(1)(A)(i). A substance is toxic if it
``has the capacity to produce personal injury or illness to man through
ingestion, inhalation, or absorption through any body surface.'' 15
U.S.C. 1261(g). As discussed in section IV, staff has identified HFC-
152a and HFC-134a as two toxic hydrofluorocarbons used as propellants
in aerosol duster products. Both hydrofluorocarbons are intentionally
inhaled by individuals to experience a euphoric high, resulting in
numerous deaths and injuries. Severe HFC-152a toxicity can cause a
depressed mental state, respiratory depression, pulmonary edema,
hepatic injury, and death (Poisindex, 2021). Symptoms of acute HFC-134a
toxicity include severe hypotension, loss of consciousness, shock
(Vinegar, 1997), cardiac sensitization, neurotoxicity (National
Research Council, 2002), and death (Burke et al., 2020).
Staff researched published medical literature for papers regarding
the toxicity of HFC-152a and HFC-134a. While medical literature
demonstrates toxicity of the two substances, staff was unable to
identify any relevant human data regarding HFC-152a and HFC-134a that
would allow for the calculation of a non-toxic human dose. However,
that research did provide staff with data to be able to calculate a no
observed adverse effect level \36\ (NOAEL) in animals for HFC-152a. In
toxicology, it is customary to convert animal data to human data in the
absence of human data. The Food and Drug Administration (FDA), for
example, uses this approach to determine the safe dose of a drug when
studying it for the first time in human clinical trials. Based on the
generally accepted approach used by FDA, staff converted the NOAEL
found in the medical literature to calculate a human equivalent dose
(HED) using appropriate scaling factors.\37\ Staff used the resulting
HED it developed to determine the safe level for the proposed ban after
applying a safety factor of 10.\38\ Below is a description of the staff
approach used in developing the level for the proposed ban on HFC-152a
and HFC-134a.
---------------------------------------------------------------------------
\36\ A NOAEL is the highest dose level that does not produce a
significant increase in adverse effects in comparison to the control
group. The NOAEL is a generally accepted benchmark for safety when
derived from appropriate animal studies.
\37\ Scaling factors account for differences in size between
animals and humans. See FDA, 2005, Guidance for Industry Estimating
the Maximum Safe Starting Dose in Initial Clinical Trials for
Therapeutics in Adult Healthy Volunteers (FDA Guidance), available
at: <a href="http://www.fda.gov/regulatory-information/search-fda-guidance-documents/estimating-maximum-safe-starting-dose-initial-clinical-trials-therapeutics-adult-healthy-volunteers">www.fda.gov/regulatory-information/search-fda-guidance-documents/estimating-maximum-safe-starting-dose-initial-clinical-trials-therapeutics-adult-healthy-volunteers</a>.
\38\ A safety factor allows for variability in extrapolating
from animal toxicity studies in humans resulting from: (1) different
sensitivity of drugs to animals and humans; (2) differing receptor
affinity to drugs between animals and humans; (3) unexpected
toxicities; and (4) interspecies differences between the metabolism
and time course effect of drugs between animals and humans. Ten is a
default value for a safety factor. An additional safety factor of 10
could be used to protect sensitive populations.
---------------------------------------------------------------------------
A study was conducted on groups of three rats to mimic the exposure
of humans while inhaling HFC-152a (Avella et al., 2010). The rats were
exposed to 30 seconds (s) of 20 L/min HFC-152a in an inhalation
chamber. During that exposure, all the rats showed signs of
intoxication manifested by sedation which began at about 20 s and
rapidly progressed to more profound intoxication. At the end of the
exposure periods the rats were prostrate and could not get up. The rats
remained visibly intoxicated until about four minutes post exposure.
Recovery was rapid, and at about eight minutes post exposure, the rats
showed no signs of obvious intoxication. Staff calculated a non-toxic
human dose of 0.476 mg/kg using the information in the Avella et al.,
2010 paper and applying an additional safety factor of 10 for a total
safety factor of 100 (see footnote 38 for explanation regarding safety
factors). The resulting calculation for a non-toxic human dose is
equivalent to 18 mg for 38 kg human (5th percentile weight for 13-year-
old female).\39\
---------------------------------------------------------------------------
\39\ This dose will be at least as protective for older females
and males of the same age and older due to their higher weight.
Anthropometric reference data for children and adults: United
States, 2015-2018; <a href="https://stacks.cdc.gov/view/cdc/100478">https://stacks.cdc.gov/view/cdc/100478</a>.
---------------------------------------------------------------------------
Although there are no relevant human inhalation toxicology studies
available regarding HFC-134a, the injury and death evidence and
properties of HFC-134a discussed above demonstrate a similar hazard to
that presented by HFC-152a. HFC-134a has somewhat lower inhalational
toxicity in rats compared to HFC-152a (Rusch, 2018). Therefore, the
non-toxic dose calculated for HFC-152a will be also protective for HFC-
134a.
Based on the assessment that individuals who inhale aerosol duster
products inhale a single spray at a time, but may use multiple sprays
within a single period of use, and applying the conversion process
described above, staff concluded that a single canister of aerosol
duster product should be limited to 18 mg or less of HFC-152a and/or
HFC-134a to render it non-toxic to humans. Although 18 mg of HFC-
[[Page 61374]]
152a or HFC-134a is too small an amount to effectively be used as a
propellant in an aerosol duster product, because this amount of
propellant is not harmful, the Commission is proposing to allow trace
amounts of 18 mg or less of HFC-152a and/or HFC-134a in aerosol duster
products to allow for low level contamination that may occur during the
manufacturing process. For example, if a manufacturer made a propellant
change from the manufacture of an unregulated product to a regulated
aerosol duster product, leftover contaminant levels remaining in hose
lines used to fill aerosol duster products during manufacturing would
not result in violative products as long as there is 18 mg or less per
canister of the banned propellants. Therefore, the Commission
preliminarily finds that any aerosol duster product containing more
than 18 mg in any combination of HFC-152a and/or HFC-134a is toxic, and
thus, is a hazardous substance under the FHSA.
Under the FHSA, the Commission may classify a hazardous substance
that is packaged in a form suitable for use in the household as a
``banned hazardous substance'' if the Commission finds that
``notwithstanding such cautionary labeling as is or may be required
under this chapter for that substance, the degree or nature of the
hazard involved in the presence or use of such substance in households
is such that the objective of the protection of the public health and
safety can be adequately served only by keeping such substance, when so
intended or packaged, out of the channels of interstate commerce.'' 15
U.S.C. 1261(q)(1)(B). The Commission preliminary makes such a finding
for HFC-152a and HFC-134a used in aerosol duster products.
Aerosol duster products are sold to consumers for use in their
homes, and almost all aerosol duster products currently on the market
display cautionary labeling including at a minimum a signal word
(POISON, DANGER, WARNING, CAUTION) and statement(s) of principal
hazard(s) such as FLAMMABLE and VAPOR HARMFUL as required by the FHSA
and 16 CFR 1500.121. Aerosol duster products on the market also contain
statements to inform consumers of intentional misuse, inhalation abuse,
and the potential consequences of either activity. Tab C in the July
20, 2022, staff briefing package contains an in-depth analysis
regarding the labeling of aerosol duster products.\40\
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\40\ <a href="http://www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard_0.pdf?VersionId=GNEl7pYZUBOxf1BLSC0f4.X6TlA8gT4f">www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard_0.pdf?VersionId=GNEl7pYZUBOxf1BLSC0f4.X6TlA8gT4f</a>.
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Although current aerosol duster products on the market contain both
FHSA-required labeling, as well as statements identifying the potential
hazard of aerosol duster abuse and misuse, these labels have not
prevented the more than 1,000 deaths described in section IV of the
preamble. The Commission therefore preliminary finds that labeling of
aerosol duster products does not effectively address the inhalation
hazard presented by aerosol duster products. Because large numbers of
deaths and injuries continue to occur despite the cautionary labeling
on aerosol duster products, the Commission is proposing to ban the use
of toxic propellants HFC-152a and HFC-134a in any aerosol duster
canister in amounts above 18 mg.
VII. Description of the Proposed Rule
The proposed rule would amend 16 CFR part 1500 to add a new
provision under 16 CFR 1500.17 declaring any canister of aerosol duster
product containing more than 18 mg in any combination of HFC-152a and/
or HFC-134a to be a banned hazardous substance under the FHSA. The
provisions of the proposed ban are described below.
A. Proposed Sec. 1500.17(a)(14)(i)--Ban on Aerosol Duster Products
Containing More Than 18 mg in Any Combination of HFC-152a and/or HFC-
134a
The proposed rule would add a new paragraph, Sec.
1500.17(a)(14)(i) to 16 CFR 1500.17, that would declare any canister of
aerosol duster product containing more than 18 mg in any combination of
1,1-difluoroethane (HFC-152a, CAS #75-37-6) and/or 1,1,1,2-
tetrafluoroethane (HFC-134a, CAS #811-97-2) to be a banned hazardous
substance under section 2(q)(1) of the FHSA. Section VI of the preamble
provides the technical justification for the proposed ban. Proposed
Sec. 1500.17(a)(14)(i) also defines ``aerosol duster product'' to mean
a product that uses a pressurized canister filled with gas or liquified
gas to create a stream of gas propellant that can be used to dislodge
or remove dust and debris.
B. Proposed Sec. 1500.17(a)(14)(ii)--Prohibited Stockpiling
Pursuant to section 9(g)(2) of the CPSA, 15 U.S.C. 2058(g)(2),
Sec. 1500.17(a)(14)(ii) of the proposed rule would prohibit a
manufacturer from ``stockpiling'' or substantially increasing the
manufacture or importation of noncompliant aerosol duster products
between the date of publication of the final rule and the effective
date. Section 9(g)(2) defines stockpiling to mean manufacturing or
importing a product between the date of promulgation of a rule,
regulation, standard, or ban and its effective date at a rate which is
significantly greater than the rate at which such product was produced
or imported during a base period ending before the date of promulgation
of the rule standard, or ban. The proposed stockpiling provision for
hazardous aerosol dusters, which is explained more fully in Tab A of
the staff NPR briefing package \41\, would prohibit the manufacture or
importation of noncompliant aerosol duster products in any one-month
period between the date of publication of the final rule and the
effective date of the final rule at a rate greater than 105 percent of
the rate at which they were manufactured or imported during the base
period for the manufacturer or importer. The base period for aerosol
duster products is defined in the proposed rule as the average monthly
manufacture or import volume for the last 13 months immediately
preceding the month of the publication of the final rule.
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\41\ <a href="https://cpsc.gov/s3fs-public/Briefing-Package-Draft-Proposed-Rule-Aerosol-Duster-Products.pdf?VersionId=m8a.WZmo3DJvX0U3qR.EbOr4yQU9yeps">https://cpsc.gov/s3fs-public/Briefing-Package-Draft-Proposed-Rule-Aerosol-Duster-Products.pdf?VersionId=m8a.WZmo3DJvX0U3qR.EbOr4yQU9yeps</a>.
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C. Proposed Sec. 1500.17(a)(14)(iii)--Findings
Proposed Sec. 1500.17(a)(14)(iii) describes the Commission's
preliminary findings required under sections 2(q)(1) and 3(h) of the
FHSA, including requirements regarding voluntary standards,
relationship of benefits to costs, and the least burdensome
requirement.
VIII. Preliminary Regulatory Analysis
Pursuant to section 3(h) of the FHSA, publication of a proposed
rule must include a preliminary regulatory analysis containing:
<bullet> a preliminary description of the potential benefits and
potential costs of the proposed rule, including any benefits or costs
that cannot be quantified in monetary terms, and an identification of
those likely to receive the benefits and bear the costs;
<bullet> a discussion of why a relevant voluntary safety standard
would not eliminate or adequately reduce the risk of injury addressed
by the proposed rule;
<bullet> a discussion of the reasons for the Commission's
preliminary determination of why the voluntary standards process would
not within a reasonable time result in the development of a voluntary
standard that would eliminate or adequately
[[Page 61375]]
reduce the risk of injury identified in the rule; and
<bullet> a description of any reasonable alternatives to the
proposed rule, together with a summary description of their potential
costs and benefits and why such alternatives should not be published as
a proposed rule.
15 U.S.C. 1262(h).
Below is a summary of the preliminary regulatory analysis for the
proposed rule. See Tab A of the staff NPR briefing package \42\ for the
complete preliminary regulatory analysis.
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\42\ <a href="https://cpsc.gov/s3fs-public/Briefing-Package-Draft-Proposed-Rule-Aerosol-Duster-Products.pdf?VersionId=m8a.WZmo3DJvX0U3qR.EbOr4yQU9yeps">https://cpsc.gov/s3fs-public/Briefing-Package-Draft-Proposed-Rule-Aerosol-Duster-Products.pdf?VersionId=m8a.WZmo3DJvX0U3qR.EbOr4yQU9yeps</a>.
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A. Market Information
1. The Product
Aerosol duster products, also known as canned air, are pressurized
canisters filled with liquified gas propellant. They utilize the force
of compressed gas, released through a nozzle or straw attachment, to
create a direct stream of gas that dislodges and blows away debris.
Many aerosol duster products are labeled for ``electronics dusting,''
or more generically, as a ``multi-purpose duster.'' These products are
marketed for dusting laptops, keyboards, computers, TVs, phones,
printers, electronic toys, gaming devices, and other common household
products including sewing machines, clocks, watches, musical
instruments, and for auto detailing.
Other alternative products that would not be subject to the
proposed ban exist for consumers to use for similar dusting purposes,
including aerosol duster products using the propellant HFO-1234ze,
compressed air dusters which use corded or cordless electric pumps, or
even hand pumps, to compress air and blow it through a nozzle,
CO<INF>2</INF> cartridge dusters which use disposable CO<INF>2</INF>
cartridges to blow CO<INF>2</INF> through a nozzle, as well as vacuum
cleaners.
While prices for aerosol duster products vary widely, the average
price for a canister of aerosol duster is $8.00 according to a Maia
Research market report \43\ and $10.19 according to the Aerosol Duster
Market Report available on the CPSC website.\44\ Aerosol duster
products that use HFC-152a as a propellant are most common due to this
propellant being less expensive than the less common alternative
propellants HFC-134a or HFO-1234ze (trans-1,3,3,3-tetrafluoropropene).
HFC-134a is non-flammable but is considered a potential greenhouse gas.
HFO-1234ze was introduced as an environmentally friendly alternative to
HFC-134a, with low global warming potential. (See the staff's
preliminary regulatory analysis in Tab A of the staff NPR briefing
package for a more complete discussion of aerosol duster products and a
complete list of references.)
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\43\ Maia Research (January 2024). United States Air Duster
Industry Market Research Report. 2025 price estimate, deflated to
2023 dollars using CPI.
\44\ <a href="http://www.cpsc.gov/content/Aerosol-Duster-Study-Final-Report">www.cpsc.gov/content/Aerosol-Duster-Study-Final-Report</a>.
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2. Market Trends for Aerosol Duster Products
Firms that sell aerosol duster products typically engage in either
contract manufacturing or are private labelers. Typically, a company
that engages in contract manufacturing has another company produce
their product for them but remain involved in all components of
manufacturing by providing specifications. When a company engages in
contract manufacturing, the firm owns the end products for which they
have contracted out production. Similarly, private labelers have their
production manufactured by a third party; however, the product is owned
by that third party and can be sold to other companies, as well.
Typically, a private labeler owns a brand name and buys products from
the third party to sell it under their established brand. While
slightly different in structure, both of these arrangements (contract
manufacturing and private labeling) allow firms that produce aerosol
duster products to benefit from flexibility in their production
processes, and typically avoid large, fixed manufacturing costs to
produce their products.
3. Future Market Size for Aerosol Duster Products
Staff forecast aerosol duster products sales for a 30-year study
period (2026-2055) using data from a market research report by MAIA
Research. In this forecast, staff estimates the number of units of
aerosol duster products sold in 2026 will be 18.31 million, absent the
regulation of the product described in the proposed rule. In the
scenario without the proposed rule, staff estimates the number of units
sold in 2055 will be 35.81 million. This estimate is based on a
continuation of historical sales growth for the product, which could be
affected by a number of unknown factors such as reduced use of computer
keyboards or revised environmental regulations.
B. Preliminary Description of Potential Benefits and Costs of the
Proposed Rule
Staff conducted a benefits analysis of the proposed rule. The
benefits analysis accounted for mitigated deaths and injuries from the
proposed rule, which staff monetized using the value of statistical
life (VSL) for deaths and the Injury Cost Model (ICM) for injuries. As
discussed above, this is likely an undercount of benefits, because
staff's count of deaths was limited to cases where the product was
explicitly identified as an aerosol duster product. Over a 30-year
study period, staff estimated the total annualized net benefits
(benefits less costs) from the proposed rule, discounted at 2 percent,
to be $1.93 billion due to reduced fatalities and injuries from
inhalation. Stated differently, every dollar of cost from the proposed
rule is estimated to produce $16.59 of benefits.
The proposed rule would impose three main costs: (1) markup losses
to manufacturers/importers of aerosol duster products; (2) increased
prices paid by consumers; and (3) deadweight losses or market impacts
caused by the increased price associated with compliance with the
regulation and the subsequent decline in demand. As detailed in Tab A
of the staff NPR briefing package, staff estimates that these costs
total $123.73 million over the 30-year study period, discounted at 2
percent.
When the estimated benefits of $2.05 billion are compared to the
estimated costs of $123.73 million, the estimated benefits of the rule
are far greater than the estimated costs. Staff calculates net benefits
(benefits less costs) to be $1.93 billion on an annualized basis, after
discounting at 2 percent. However, staff notes that one of the
unquantified costs of the proposed rule is the assumed creation of a
black market for noncompliant aerosol duster products. Due to the
euphoric high experienced with HFC-152a and HFC-134a, consumers who use
aerosol duster products as inhalants may still want to purchase
noncompliant canisters. This inelastic demand and significant reduction
in supply of noncompliant canisters due to the proposed rule would
create an incentive for individuals to supply those individuals with
noncompliant canisters, such as those that are illegally imported from
other countries. The creation of a black market can create significant
negative externalities such as increased illicit activity, increased
crime and subsequently increased spending on law enforcement, and
greater health and safety risks to consumers. Staff cannot estimate the
magnitude of these externalities with any certainty. In addition, this
analysis does not consider individuals who may stop inhaling aerosol
duster products after the rule goes into effect but start using other
[[Page 61376]]
intoxicants in its place. If staff were able to forecast and quantify
this effect, the impact could reduce the estimated benefits from the
proposed rule. However, given the net estimated benefits of $1.93
billion per year in staff's analysis, the benefits of the proposed rule
would likely still outweigh the costs even if these externalities
occur.
To investigate the impact of using alternative values for some of
the key inputs and assumptions of the analysis, staff conducted a
sensitivity analysis to compare with the main preliminary regulatory
analysis. In the main preliminary regulatory analysis, staff assumes a
large number of individuals would continue to use most aerosol duster
products obtained on the black market as inhalants due to the euphoric
high experienced with HFC-152a and HFC-134a.
In the sensitivity analysis, staff considered an alternative
scenario. The sensitivity analysis assumes that the prohibition of HFC-
152a and HFC-134a in aerosol duster products results in a greater
reduction in inhalant abuse. Staff estimated that, currently, 7.88
percent of aerosol duster products are potentially used by consumers as
inhalants. After the regulation goes into effect, staff estimated that
there would be an overall reduction in products used as inhalants, but
the share of products used as inhalants increases to about 30 percent.
In the sensitivity analysis, staff assumes that the share of products
used as inhalants is unchanged at 7.88 percent. This change in input
inherently assumes that the proposed rule would be more effective at
changing the behavior of consumers who use aerosol duster products as
inhalants.
This change in assumption increases benefits without affecting the
costs. In this scenario, net benefits increase to $2.94 billion when
annualized at 2 percent, which boosts the benefit-cost ratio from
$16.59 of benefits for every $1 of cost shown in the main preliminary
regulatory analysis, to $24.78 of benefit for every $1 of cost show in
the sensitivity analysis.
C. Evaluation of Voluntary Standards
Based on the current state of the voluntary standard's process for
aerosol duster products discussed in section V of the preamble, the
Commission determines that no current U.S. voluntary standard exists to
address the inhalation hazard posed by aerosol duster products.
Further, there is no indication that any voluntary standards
organization has a clear plan to address the inhalant hazard in a new
or existing voluntary standard. Therefore, the Commission preliminarily
determines at this time that the voluntary standard's process will not
within a reasonable time result in the development of a voluntary
standard that would eliminate or adequately reduce the risk of injury
identified in the proposed rule. No standard or portion of a standard
has been submitted to the Commission under sections 3(f)(5) and (6) of
the FHSA.
D. Alternatives to the Proposed Rule
The Commission considered four alternatives to the proposed rule:
(1) performance requirements; (2) aversive agents (bitterants); (3)
labeling; and (4) take no regulatory action and rely upon the voluntary
standard's process. The Commission finds that none of these
alternatives would adequately address the inhalation hazard associated
with aerosol duster products.
1. Performance Requirements
Rather than banning hazardous aerosol duster products under the
FHSA, the Commission could in principle mandate a performance
requirement under sections 7 and 9 of the CPSA, 15 U.S.C. 2056, 2058,
aimed at making aerosol duster products using the propellants HFC-152a
and HFC-134a less likely to be used for inhalation. This alternative
assumes that an effective performance standard for preventing aerosol
duster abuse could be developed. To date, however, suppliers have been
unable to develop a performance standard that would effectively prevent
the inhalation abuse of aerosol duster products while still allowing
for use of the product as intended. Staff is unaware of any existing
voluntary standard to address the inhalation hazard. In March 2024,
ASTM considered establishing a task group to develop a standard, but no
task group was formed. Incident data indicates that victims of injury
and death are primarily adults who purchase aerosol duster products
with the intended goal of intentionally inhaling the product. Even
assuming a performance requirement could be developed, while such a
requirement may be effective in preventing young children from
releasing the contents of aerosol duster products by adding child-safe
features, it would not be effective in preventing adults from abusing
and inhaling aerosol duster products, and notably the overwhelming
number of injuries and deaths occur among adults. Thus, it would be
very difficult, if not impossible, to develop a performance standard
that would be effective in addressing inhalant abuse of aerosol duster
products. Therefore, the Commission finds this alternative would not
address the unreasonable risk of injury associated with aerosol duster
products.
2. Aversive Agents (Bitterants)
As FUAIA recommended in its 2021 rulemaking petition, the
Commission could adopt a CPSA performance standard to require aversive
agents (bitterants) to be used in aerosol duster products. At the
petition stage, staff evaluated the use of aversive agents such as
bitterants in aerosol duster products and concluded that adding
bitterants would not be effective at addressing the inhalant hazard
posed by aerosol duster products. Tab B in the July 20, 2022 staff
briefing package contains an in-depth analysis regarding the use of
bitterants in aerosol duster products.\45\ Additionally, many aerosol
duster products currently on the market contain bitterants,\46\ which
appears not to have led to a decline in deaths and injuries associated
with inhalant abuse of aerosol duster products. Therefore, the
Commission finds this alternative would not adequately address the
unreasonable risk of injury associated with aerosol duster products.
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\45\ <a href="http://www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard_0.pdf?VersionId=GNEl7pYZUBOxf1BLSC0f4.X6TlA8gT4f">www.cpsc.gov/s3fs-public/Petition-Requesting-Rulemaking-to-Establish-Safety-Standard_0.pdf?VersionId=GNEl7pYZUBOxf1BLSC0f4.X6TlA8gT4f</a>.
\46\ According to the Aerosol Duster Study completed by
Euromonitor International in July 2023, approximately 70 percent of
all aerosol duster sales are of bitterant-containing products.
(<a href="https://www.cpsc.gov/s3fs-public/Aerosol-Duster-Study-2023-Redacted.pdf?VersionId=idRW1RnIfr_5Jkc9sA9mkss8kTyUmZDD">https://www.cpsc.gov/s3fs-public/Aerosol-Duster-Study-2023-Redacted.pdf?VersionId=idRW1RnIfr_5Jkc9sA9mkss8kTyUmZDD</a>).
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3. Labeling
The Commission could require warning and other labels on aerosol
duster products. However, most aerosol duster products currently on the
market are labeled regarding the inhalation hazard, which appears to
have had little impact on deaths and injuries associated with inhalant
abuse of aerosol duster products. Additionally, at the petition stage,
staff concluded that labeling of aerosol duster products is unlikely to
be effective at addressing the inhalation hazard posed by aerosol
duster products. In fact, labeling could have the perverse consequence
of causing people inclined to abuse inhalants to seek out products with
the enhanced warning on the label, thereby facilitating the problem
that the label was intended to avoid. Therefore, the Commission finds
this alternative would not adequately address the unreasonable risk of
injury associated with aerosol duster products.
[[Page 61377]]
4. Take No Regulatory Action and Rely Upon the Voluntary Standard's
Process
The Commission could take no regulatory action and rely upon the
voluntary standard's process to address the inhalation hazard posed by
aerosol duster products. Currently, however, no U.S. voluntary standard
exists or is under consideration to address the inhalation hazard posed
by aerosol duster products. Therefore, as discussed in section V of
this preamble, the Commission finds this alternative would not
adequately address the unreasonable risk of injury associated with
aerosol duster products.
IX. Initial Regulatory Flexibility Analysis
Whenever an agency publishes an NPR, section 603 of the Regulatory
Flexibility Act (RFA), 5 U.S.C. 601-612, requires the agency to prepare
an initial regulatory flexibility analysis (IRFA), unless the head of
the agency certifies that the rule will not have a significant economic
impact on a substantial number of small entities. The IRFA, or a
summary of it, must be published in the Federal Register with the
proposed rule. Under section 603(b) of the RFA, each IRFA must address:
(1) a description of why action by the agency is being considered;
(2) a succinct statement of the objectives of, and legal basis for,
the proposed rule;
(3) a description of and, where feasible, an estimate of the number
of small entities to which the proposed rule will apply;
(4) a description of the projected reporting, recordkeeping, and
other compliance requirements of the proposed rule, including an
estimate of the classes of small entities which will be subject to the
requirement and the type of professional skills necessary for
preparation of the report or record; and
(5) an identification, to the extent practicable, of all relevant
Federal rules which may duplicate, overlap, or conflict with the
proposed rule.
The IRFA must also describe any significant alternatives to the
proposed rule that would accomplish the stated objectives and that
minimize any significant economic impact on small entities.
A. Reason for Agency Action
The intent of the proposed rulemaking is to reduce deaths and
injuries associated with inhalant abuse of aerosol duster products. The
Commission is considering the action because of the numerous deaths and
injuries associated with the use of aerosol duster products.
B. Objectives of and Legal Basis for the Rule
The Commission proposes this rule to reduce death and injury
associated with inhalant abuse from aerosol duster products. This
standard is promulgated under the authority of the FHSA. To declare a
substance a banned hazardous substance under section 2(q)(1) of the
FHSA the Commission must follow the procedural requirements set forth
in section 3(f)-(i) of the FHSA. See 15 U.S.C. 1261(q)(2) and 1262(f)-
(i).
C. Small Entities To Which the Rule Will Apply
The proposed rule would apply to all manufacturers and importers of
aerosol duster products. According to estimates by Euromonitor
International (Euromonitor), the household consumer market for aerosol
duster products was $99.7 million in 2022, and approximately 87 percent
of aerosol duster products examined use the propellant HFC-152a and 11
percent use HFC-134a. The remainder use a mixture of these two
propellants or an alternative propellant.
According to information collected by staff, in 2024 there were an
estimated 31 firms that supply the domestic market for aerosol duster
products. Among these firms, 26 are manufacturers and five are
importers/wholesalers. Approximately 90 percent of suppliers (28
suppliers) are located domestically in the United States.
D. Compliance, Reporting, and Record-Keeping Requirements of Proposed
Rule
In accordance with section 14 of the CPSA, 15 U.S.C. 2063,
manufacturers would have to issue a General Certificate of Conformity
(GCC) for each aerosol duster product model, certifying that the model
complies with the proposed ban. Each GCC must also be based on a test
of each product or a reasonable testing program and provided to all
distributors or retailers of the product. The manufacturer would have
to comply with 16 CFR part 1110 concerning the content of the GCC,
retention of the associated records, and any other applicable
requirements.
E. Federal Rules That May Duplicate, Overlap, or Conflict With the
Proposed Rule
CPSC currently has no regulations regarding the use of HFC-152a
and/or HFC-134a in aerosol duster products or any other consumer
product. However, the U.S. EPA regulates, or is in the process of
regulating, the use of HFC-152a and HFC-134a as hydrofluorocarbons for
various uses, including for use in motor vehicle air conditioning, as
refrigerants for use in self-chilling cans for household refrigeration,
transport refrigeration, vending machines, cold storage warehouses and
retail food refrigeration (40 CFR part 82), and as per- and
polyfluoroalkyl substances (PFAS) which are broadly used in food,
water, and increasingly consumer products, as exposure to some types of
PFAS substances are linked to serious health effects. None of EPA's
regulations regulating HFC-152a and HFC-134a address the inhalation
hazard the proposed rule is intended to address, and thus do not
overlap or conflict with the proposed rule.
F. Potential Impact on Small Entities
1. Impact on Small Manufacturers
For the majority of firms in this market, aerosol duster products
are ancillary to their manufacturing of products such as degreasers,
lubricants and other aerosol products that would not be regulated under
the proposed rule. Staff identified 31 firms that would be impacted by
the proposed rule. Twenty-six of these firms are manufacturers of
aerosol duster products and five are wholesales/importers. Among the 26
manufacturers of aerosol duster products, 20 would be considered small
firms according to Small Business Administration (SBA) thresholds.\47\
The SBA size standard threshold for NAICS code 325998, All Other
Miscellaneous Chemical Product and Preparation Manufacturing, is having
fewer than 650 employees in order to be considered small.
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\47\ Small Business Administration, Table of Size Standards
(<a href="https://www.sba.gov/document/support-table-size-standards">https://www.sba.gov/document/support-table-size-standards</a>).
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Staff identified four small domestic manufacturers of aerosol
duster products where the potential impact of the proposed regulation
could be significant. These firms enjoy strong brand recognition, and
their products are widely used aerosol duster products for electronics.
For these firms, their aerosol duster products comprise a large share
of their total product offerings. Staff assessed the impact to these
small manufacturers to be significant (i.e., greater than one percent
of annual revenue) as the proposed rule is expected to increase the
price of a canister of aerosol duster product more than threefold, and
subsequently cause a steep decline in demand.\48\
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\48\ The proposed rule is expected to cause firms to shift to
more expensive propellants, and therefore is expected to increase
the price of a canister of aerosol duster product. For a more
complete discussion of the expected price increase and subsequent
projected decline in demand, see the full economics memorandum in
Tab A.
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[[Page 61378]]
2. Impact on Small Importers
Staff identified five wholesalers/importers of aerosol duster
products. The SBA size standard threshold for NAICS code 424690, Other
Chemical and Allied Products Merchant Wholesalers, is having fewer than
175 employees in order to be considered small. According to SBA size
standards, two of these firms would be considered small and three would
be considered large. Staff assessed the impact to these small importers
and wholesalers to be significant (i.e., greater than one percent of
annual revenue) as the proposed rule is expected to increase the price
of a canister of aerosol duster product more than threefold, and
subsequently cause a steep decline in demand.
3. Conclusion
Given the significant impact that the proposed rule would have on
the market overall, staff assessed that there would be a significant
impact on a substantial number of small entities from the proposed
rule.
G. Alternatives for Reducing the Adverse Impact on Small Businesses
Section VIII.D Preliminary Regulatory Analysis of this preamble
provides a discussion of four alternatives to the proposed rule that
were considered and why those alternatives were rejected. While the
alternatives could reduce the burden on small entities, none of the
alternatives are consistent with achieving the rule's objective of
improving consumer safety by protecting consumers from the inhalant
risks posed by aerosol duster products. The Commission is not proposing
these alternatives because they would not effectively reduce the number
of injuries and fatalities associated with aerosol duster products as
discussed in section VIII of the preamble.
The Commission welcomes public comments on this IRFA. Small
businesses that believe they would be affected by the proposed rule are
encouraged to submit comments. The comments should be specific and
describe the potential impact, magnitude, and alternatives that could
reduce the impact of the proposed rule on small businesses.
X. Paperwork Reduction Act
This proposed rule contains information collection requirements
that are subject to public comment and review by the Office of
Management and Budget (OMB) under the Paperwork Reduction Act of 1995
(PRA). 44 U.S.C. 3501-3521. We describe the provisions in this section
of the document with an estimate of the annual reporting burden. Our
estimate includes the time for gathering certificate data and creating
General Certificates of Conformity (GCCs), the keeping and maintaining
of records associated with the GCCs, and the disclosure of GCCs to
distributors and retailers.
CPSC particularly invites comments on: (1) whether the collection
of information is necessary for the proper performance of the CPSC's
functions, including whether the information would have practical
utility; (2) the accuracy of CPSC's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) the accuracy of CPSC's estimate
of the share of canisters used as inhalants; (4) ways to enhance the
quality, utility, and clarity of the information to be collected; (5)
ways to reduce the burden of the collection of information on
respondents, including the use of automated collection techniques, when
appropriate, and other forms of information technology; and (6)
estimated burden hours associated with label modification, including
any alternative estimates.
Title: Ban on Specified Aerosol Duster Products.
Description: The proposed rule would ban any canister of an aerosol
duster product containing more than 18 mg in any combination of HFC-
152a and/or HFC-134a.
Description of Respondents: Persons who manufacture or import
aerosol duster products. Staff estimates the burden of this collection
of information as follows in Table 9.
Table 9--Estimated Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
Total Total
Burden type Number of Frequency of annual Minutes per burden
respondents responses responses response hours
----------------------------------------------------------------------------------------------------------------
GCC Creation......................... 30 5 150 20 50
Recordkeeping........................ 30 5 150 2 5
Third Party Disclosure............... 30 500 15,000 5 1,250
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Total............................ .............. ............... 15,300 .............. 1,305
----------------------------------------------------------------------------------------------------------------
Section 14(a)(1) of the CPSA, 15 U.S.C. 2063(a)(1), would require
manufacturers to certify that their products conform to the proposed
rule and issue a GCC. There are 31 known corporate entities supplying
aerosol duster products to the U.S. market (consisting of 26
manufacturers and 5 wholesalers/importers), and we assume the majority
of these entities would respond annually, though this may be an
overestimate.
On average, each entity may respond 5 times per year for collection
requirements related to compliant aerosol duster products in the
market. Each manufacturer or importer that responds may create 5
certificates annually for a total of 150 responses (30 responses x 5
responses per respondent = 150 annual responses). The estimated time
required to create a GCC is about twenty minutes. Therefore, the
estimated burden associated with issuance of GCCs is 50 hours (150
responses x 20 minutes per response = 50 hours).
We estimate for the purpose of this burden analysis that records
supporting GCC creation, including testing records, would be maintained
for a 5-year period. Staff estimates another 150 record-keeping
responses, each one of which requires two minutes per year in routine
recordkeeping. This adds up to 5 hours (150 records x 2 min per record
= 300 minutes or 5 hours).
Section 14(g)(3) of the CPSA also requires that GCCs be disclosed
to third party retailers and distributors. We estimate that each
respondent will submit 5 GCCs to 100 retailers or distributors
annually. Therefore, respondents are estimated to disclose 15,000 GCCs
to third party retailers and
[[Page 61379]]
distributors annually (30 responses x 500 disclosures per year = 15,000
responses). Staff estimates each one of which requires 5 minutes per
year. This adds up to 1,205 hours (15,000 responses x 5 minutes per
response = 75,000 minutes or 1,250 hours).
Based on this analysis, the proposed ban for aerosol duster
products would impose a total paperwork burden to industry of 1,305
hours (50 hours for GCC creation + 5 hours for recordkeeping + 1,250
hours for third-party disclosure). To estimate the cost to industry
staff uses total compensation data from the U.S. Bureau of Labor
Statistics (BLS) on hourly compensation paid to private industry
workers in goods-producing industries of $44.75.\49\ At an hourly wage
rate of $44.75, the estimated cost of the collection is $58,399
annually (1,305 hours x $44.75 = $58,398.75). There are no operating,
maintenance, or capital costs associated with the collection.
---------------------------------------------------------------------------
\49\ U.S. Bureau of Labor Statistics, ``Employer Costs for
Employee Compensation,'' December 2023, Table 4, total compensation
for private industry working in goods-producing industries: <a href="https://www.bls.gov/news.release/archives/ecec_03132024.pdf">https://www.bls.gov/news.release/archives/ecec_03132024.pdf</a>.
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Existing aerosol duster product manufactures would incur these
costs in the first year following the proposed rule's effective date.
In subsequent years, costs could be less, depending on the number of
new GCCs issued for aerosol duster products. As required under the PRA
(44 U.S.C. 3507(d)), CPSC has submitted the information collection
requirements of this proposed rule to the OMB for review. Interested
persons are requested to submit comments regarding information
collection by September 30, 2024, to the Office of Information and
Regulatory Affairs, OMB as described under the ADDRESSES section of
this notice.
XI. Effective Date
The FHSA does not specify any requirements regarding the setting of
an effective date for a rule promulgated pursuant to that authority.
The Administrative Procedure Act (APA) generally requires that the
effective date of a rule be at least 30 days after publication of a
final rule. 5 U.S.C. 553(d).
The Commission preliminarily proposes an effective date of 30 days
after publication of the final rule in the Federal Register. Pursuant
to section 19(a)(2)(D) of the CPSA, once the rule is effective, it
would be unlawful to ``sell, offer for sale, manufacture for sale,
distribute in commerce, or import into the United States'' any aerosol
duster product containing 18 mg in any combination of HFC-152a and/or
HFC-134a. 15 U.S.C. 2068(a)(2)(D). Therefore, it would be unlawful to
sell any remaining inventory of aerosol duster products containing more
than 18 mg of HFC-152a or HFC-134a as of the effective date.
While there are potential vulnerabilities regarding shortages and
revenue loss, these potential vulnerabilities are greatly outweighed by
the reduction in benefits that would result from delaying the effective
date past 30 days. Staff estimates the incremental loss in benefits
from a 60-day effective date--30 additional days from the recommended
30-day effective date--to be $45.71 million in net benefits, using a 2
percent discount rate. This loss is the result of 246 additional
injuries and 3 additional deaths from delaying the rule for an
additional 30 days. Under a 180-day effective date--150 additional days
from the recommended 30-day effective date--staff estimates a loss of
$228.57 million in net benefits. This estimated further loss is the
result of 1,229 additional injuries and 17 additional deaths from
delaying the rule for 150 days.
Staff also considered manufacturers' expected actions required to
become compliant with the proposed ban in recommending the 30-day
effective date. Manufacturers of aerosol duster products would switch
to an alternative propellant. Switching to an alternative propellant is
a near drop-in replacement, having only minimal changes required to
formulations and equipment. As such, while the new propellant itself
will be more expensive, the one-time costs of switching propellants
will be negligible. The manufacturing process which includes filling,
sealing, and crimping the aerosol duster products remains unchanged
from current manufacturing practices. It would also require
manufacturers to change the labels on their canister to list the
alternative propellant, which staff assesses can be accomplished in 30
days. Therefore, the cost of any retooling in the manufacturing process
would be minimal. In addition, consumer aerosol duster products that
would not be impacted by the proposed rule are already in use, and
available for sale. Alternatively, instead of switching to a new
propellant in an aerosol duster product, as discussed in section III.C
of this preamble, there are manufacturers and importers that currently
supply battery powered USB rechargeable duster products to the market,
which provide similar utility to consumers as an aerosol duster
product. For these reasons, the Commission proposes a 30-day effective
date. The Commission invites comments regarding the amount of time
needed to come into compliance with a final rule.
XII. Certification
Section 14(a)(1) of the CPSA requires that products subject to a
consumer product safety rule under the CPSA, or to a similar rule, ban,
standard or regulation under any other act enforced by the Commission,
must be certified with a GCC as complying with all applicable CPSC-
enforced requirements. 15 U.S.C. 2063(a)(1). A final rule establishing
a ban under the FHSA would subject aerosol duster products to this
requirement. Aerosol duster products would need a certification stating
that they do not contain more than 18 mg in any combination of HFC-152a
and/or HFC-134a.
XIII. Environmental Considerations
Generally, the Commission's regulations are considered to have
little or no potential for affecting the human environment, and
environmental assessments and impact statements are not usually
required. See 16 CFR 1021.5(a). The proposed rule is not expected to
have an adverse impact on the environment and is considered to fall
within the ``categorical exclusion'' for the purposes of the National
Environmental Policy Act. 16 CFR 1021.5(c). In fact, because HFO-1234ze
was introduced as an environmentally friendly alternative to HFC-134a,
substitution of HFO-1234ze for HFO-134a in aerosol duster products as a
result of the proposed rule could have beneficial environmental
effects.
XIV. Preemption
Executive Order (E.O.) 12988, Civil Justice Reform (Feb. 5, 1996),
directs agencies to specify the preemptive effect of a rule in the
regulation. 61 FR 4729 (Feb. 7, 1996). The proposed ban on any aerosol
duster canister containing more than 18 mg in any combination of HFC-
152a and/or HFC-134a is being promulgated under the authority of the
FHSA. 15 U.S.C. 1261-1278. The FHSA provides that, generally, if the
Commission issues a banning rule under section 2(q) of the FHSA to
protect against a risk of illness or injury associated with a hazardous
substance, ``no State or political subdivision of a State may establish
or continue in effect a requirement applicable to such substance and
designed to protect against the same risk of illness or injury unless
such requirement is identical to the requirement established under such
regulations.'' 15 U.S.C. 1261 Note. Upon application to the Commission,
a State or local standard may be excepted from
[[Page 61380]]
this preemptive effect if the State or local standard: (1) provides a
higher degree of protection from the risk of injury or illness than the
FHSA standard and (2) does not unduly burden interstate commerce. In
addition, the Federal government, or a State or local government, may
establish and continue in effect a non-identical requirement that
provides a higher degree of protection than the FHSA requirement for
the hazardous substance for the Federal, State or local government's
own use. 15 U.S.C. 1261 note. Thus, with the exceptions noted above for
standards that provide higher levels of protection, the proposed rule
banning any aerosol duster canister containing more than 18 mg in any
combination of HFC-152a and/or HFC-134a would preempt non-identical
state or local requirements applicable to such aerosol duster products
designed to protect against the same risk of injury.
XV. Request for Comments
We invite all interested persons to submit comments on all aspects
of the proposed rule. The Commission specifically seeks comment on the
following topics:
<bullet> Alternative propellants manufacturers would likely use in
aerosol duster products and the intoxicating effects and safety
implications of inhaling these alternative propellants;
<bullet> Any test methods that can be used to test for compliance
of HFC-152a and HFC-134a at the proposed level of 18 mg per single
aerosol duster canister;
<bullet> Information or data on future market trends, including
projected sales, size of the market, growth of firms in the market,
forthcoming innovation, or any other information that would inform CPSC
of the expected future for the aerosol duster market with or without
the proposed rule; and
<bullet> The ability of firms to complete these actions to produce
compliant products within the proposed effective date.
XVI. References
Avella J, Kunaparaju N, Kumar S, Lehrer M, Zito W, Barletta M
(2010). Uptake and distribution of the abused inhalant 1,1-
difluoroethane in the rat. J. Anal. Toxicol. 34:381-388.
Beauvais F & Oetting ER (1987). Toward a clear definition of
inhalant abuse. Int J Addict. Aug;22(8):779-84.
Bass M (1970). Sudden Sniffing Death. JAMA 212:2075-2079.
Burke J, Haigney M, Farasat M, Mehler P, Krantz M (2020). Huffing
and Twist: Fatal Torsade de Pointes Associated with
Tetrafluoroethane Inhalation. Authorea. July 01, 2020. DOI: Huffing
and Twist: Fatal Torsade de Pointes Associated with
Tetrafluoroethane Inhalation.
CDC (2021). Anthropometric reference data for children and adults:
United States, 2015-2018.
Custer A, Corse A, Vazirani S (2020) Difluoroethane inhalant abuse,
skeletal fluorosis, and withdrawal. Fed Pract. 37(6):288-289.
DEA (2020). Drug Fact Sheet. Inhalants.
Dingle HE & Williams SR (2019). Multi-organ system injury from
inhalant abuse. Prehospital Emergency Care, 23:4, 580-583.
Doshi V, Kham N, Kulkarni S, Kapitan K, Henkle J, White P (1997).
HFC-134a (1,1,1,2-tetrafluoroethane) inhalation induced reactive
airways dysfunction syndrome. Am. J. Ther. 23(3):e969-71.
Duncan JR & Lawrence AJ (2013). Conventional concepts and new
perspectives for understanding the addictive properties of
inhalants. J. Pharmacol. Sci 122: 237-243.
FDA (2005). Guidance for Industry Estimating the Maximum Safe
Starting Dose in Initial Clinical Trials for Therapeutics in Adult
Healthy Volunteers. U.S. Department of Health and Human Services
Food and Drug Administration Center for Drug Evaluation and Research
(CDER).
George N, Chin B, Neeki AS, Dong F, Neeki MN (2021). Acute Inhalant-
Induced Atrial Fibrillation With Severe Hypocalcemia: A Case Report
and Review of the Pathophysiology. Cureus; 13(11):e19897.
Kamm RC (1975). Fatal arrhythmia following deodorant inhalation:
Case report Forensic Sci., Feb; 5(1):91-3.
Koehler MM & Henninger CA (2014). Orofacial and digital frostbite
caused by inhalant abuse. Cutis; 93 (5):256-260.
Micromedex Solutions, Poisindex search 2/1/2021.
National Research Council (US) Subcommittee on Acute Exposure
Guideline Levels. Acute Exposure Guideline Levels for Select
Airborne Chemicals: Volume 2. Washington (DC)
National Academies Press (US); 2002. 3,1,1,1,2-Tetraflouorethane
(HFC-134a): Acute Exposure Guideline Levels.
Peicher K & Maalofouf NM (2017). Skeletal fluorosis due to
fluorocarbon inhalation from an air dust cleaner. Calcif. Tissue.
Int. 101(5):545-548.
Perron BE, Haroney JM, Hayes D.E., Sokol RL and Kolton SA (2021).
Potentially serious consequences for the use of Bittrex as a
deterrent for the intentional inhalation of computer duster sprays.
Forensic Toxicology. 39:286-290.
Romero J, Abboud R, Elkattawy S, Romero A, Elkattawy O, Samak AAA,
Shamoon R. (2022). Troponemia secondary to air duster inhalant
abuse. EJCRIM:9: doi:10.12890/2022_003556.
Rusch GM (2018). The development of environmentally acceptable
fluorocarbons. Crit. Rev. Toxicol. 48:8, 615-665.
Seto T (2023). General anesthetic binding mode via hydration with
weak affinity and molecular discrimination: General anesthetic
dissolution in interfacial water of the common binding site of
GABA<INF>A</INF> receptor. Biophysics and Physicobiology. Jan
25;20(2): e200005: <a href="http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10941959/">www.ncbi.nlm.nih.gov/pmc/articles/PMC10941959/</a>.
Shah SB, Hariharan, Bhargava AK (2015). Anaesthetic in the garb of a
propellant. Indian Journal Anaesth. 59(4)258-260.
Shin TJ, Kim P-J, Choi B (2022). How general anesthetics work: from
the perspective of reorganized connections within the brain. Korean
J. Anesthesiol.; 75(2):124-138.
Smeeton WM & Clark MS (1985). Sudden death resulting from inhalation
of fire extinguishers containing bromochlorodifluoromethane. Med.
Sci. Law. 25:258-262.
Vinegar (1997). US Air Force Armstrong Laboratory: Human Inhalation
of Halon 1301, HFC-134a and HFC-227ea for collection of
Pharmacokinetic Data (AL/OE-TR-1997-0116).
Williams JF, Storck M and the Committee on Substance Abuse and
Committee on Native American Child Health (2007). Inhalant abuse.
American Academy of Pediatrics. 119(5):1009-1017.
Xiong Z, Avella J, Wetli CV (2004). Sudden death caused by 1,1,
difluoroethane inhalation. J. Forensic Sci. 49 (3):627-9.
List of Subjects in 16 CFR Part 1500
Consumer protection, Hazardous materials, Hazardous substances,
Imports, Infants and children, Labeling, Law enforcement, and Reporting
and recordkeeping.
For the reasons stated in the preamble, the Commission proposes to
amend 16 CFR part 1500 to read as follows:
PART 1500--HAZARDOUS SUBSTANCES AND ARTICLES: ADMINISTRATION AND
ENFORCEMENT REGULATIONS
0
1. The authority for part 1500 continues to read as follows:
Authority: 15 U.S.C. 1261-1278.
0
2. In Sec. 1500.17, add paragraph (a)(14) to read as follows:
Sec. 1500.17 Banned hazardous substances.
(a) * * *
(14)(i) Aerosol Duster Products Containing more than 18 mg in any
combination of HFC-152a and/or HFC-134a. Any canister of an aerosol
duster product containing more than 18 mg in any combination of 1,1-
difluoroethane (HFC-152a, CAS #75-37-6) and/or 1,1,1,2-
tetrafluoroethane (HFC-134a, CAS #811-97-2). The term aerosol duster
product means a product that uses a pressurized canister filled with
gas or liquified gas to create a stream of gas propellant that can be
used to dislodge or remove dust and debris.
(ii) Prohibited Stockpiling--
[[Page 61381]]
(A) Prohibited acts. Manufacturers and importers of aerosol duster
products shall not manufacture or import aerosol duster products that
do not comply with paragraph (a)(1)(i) in any one-month period between
[DATE OF PUBLICATION OF FINAL RULE] and [EFFECTIVE DATE OF THE FINAL
RULE] at a rate greater than 105 percent of the rate at which they
manufactured or imported aerosol duster products during the base period
for the manufacturer or importer.
(B) Base period. The base period for aerosol duster products is the
average monthly manufacture or import volume for any month within the
last 13 months immediately preceding the month of publication of the
final rule.
(iii) Findings--
(A) General. To issue a rule under section 2(q)(1) of the FHSA, 15
U.S.C. 1261(q)(1), classifying a substance or article as a banned
hazardous substance, the Commission must make certain findings and
include them in the regulation. These findings are discussed in
paragraphs (a)(14)(iii)(B) through (D) of this section.
(B) Voluntary standard. No voluntary standard currently exists to
address the potential for death and injury posed by inhalant abuse of
aerosol duster products containing HFC-152a or HFC-134a. The Commission
finds that there is no evidence that a voluntary standard will be
adopted and implemented within a reasonable period of time that would
eliminate or adequately reduce the risk of injury regarding the
potential for death and injury posed by the intentional inhalant abuse
of aerosol duster products.
(C) Relationship of benefits to costs. The Commission estimates
that the ban will be effective in reducing the potential for injury and
death from compliant aerosol duster products. When benefits are
compared to costs, the estimated benefits of the rule are greater than
the estimated costs. Net benefits (benefits less costs) are estimated
to be $1.93 billion on an annualized basis. Staff performed a 30-year
prospective cost analysis (2026-2055) on all cost categories and
estimated the total annualized cost from the proposed rule to be
$123.73 million. Staff estimated the total annualized benefits from the
proposed to be $2.05 billion, discounted at 2 percent.
(D) Least burdensome requirement. The Commission considered the
following alternatives: require a performance requirement for aerosol
duster products preventing inhalation of their propellant; require
aversive agents (bitterants); require warning labels; and take no
action and rely on a voluntary standard. The Commission finds none of
the alternatives considered would adequately reduce the risk of death
or injury. Therefore, the Commission finds that a ban on any aerosol
duster product containing more than 18 mg in any combination of 1,1-
difluoroethane (HFC-152a, CAS #75-37-6) and/or 1,1,1,2-
tetrafluoroethane (HFC-134a, CAS #811-97-2) is the least burdensome
requirement that would prevent or adequately reduce the risk of death
or injury.
Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2024-16716 Filed 7-30-24; 8:45 am]
BILLING CODE 6355-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.