hazardous material business plans are required by which act

Table 8—NEISS Estimates for Aerosol Duster Inhalation Injuries by Age & Gender

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. Start Printed 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.

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: https://forms.office.com/​g/​NK9WAGMhAi . 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: [email protected] .

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.

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.

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 ]

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- Start Printed 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 ]

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.

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.

The proposed rule would add a new paragraph, § 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 § 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.

Pursuant to section 9(g)(2) of the CPSA, 15 U.S.C. 2058(g)(2) , § 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.

Proposed § 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.

Pursuant to section 3(h) of the FHSA, publication of a proposed rule must include a preliminary regulatory analysis containing:

• 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;
• a discussion of why a relevant voluntary safety standard would not eliminate or adequately reduce the risk of injury addressed by the proposed rule;
• 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 Start Printed Page 61375 reduce the risk of injury identified in the rule; and
• 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.

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 2 cartridge dusters which use disposable CO 2 cartridges to blow CO 2 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.)

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.

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.

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 Start Printed 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.

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.

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.

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.

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.

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. Start Printed Page 61377

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.

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.

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.

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) .

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.

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.

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.

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.

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 ]

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.

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.

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.

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.

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 × 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 × 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 × 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 Start Printed Page 61379 distributors annually (30 responses × 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 × 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 × $44.75 = $58,398.75). There are no operating, maintenance, or capital costs associated with the collection.

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.

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.

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.

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.

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 Start Printed 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.

We invite all interested persons to submit comments on all aspects of the proposed rule. The Commission specifically seeks comment on the following topics:

• Alternative propellants manufacturers would likely use in aerosol duster products and the intoxicating effects and safety implications of inhaling these alternative propellants;
• 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;
• 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
• The ability of firms to complete these actions to produce compliant products within the proposed effective date.

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.

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• Consumer protection
• Hazardous materials
• Hazardous substances
• Infants and children
• 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:

1. The authority for part 1500 continues to read as follows:

Authority: 15 U.S.C. 1261-1278 .

2. In § 1500.17, add paragraph (a)(14) to read as follows:

(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 — Start Printed 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.

1.  The petition is available at https://www.cpsc.gov/​Regulations-Laws--Standards/​Rulemaking/​Petitions . 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).

2.   www.cpsc.gov/​s3fs-public/​Petition-Requesting-Rulemaking-to-Establish-Safety-Standard_​0.pdf?​VersionId=​GNEl7pYZUBOxf1BLSC0f4.X6TlA8gT4f .

3.   www.cpsc.gov/​s3fs-public/​RCA-Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Dusters-Products-Petition-CP-21-1.pdf?​VersionId=​uD1mraIGCZcjBd9xiyZsanVRbngVzUvP .

4.   www.cpsc.gov/​s3fs-public/​Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?​VersionId=​.NohA6DG6WsXh_​tsjhGuA7RuqMCOvxSW .

5.   www.cpsc.gov/​s3fs-public/​RCAPetitionRequestingRulemakingtoEstablishSafetyStandardforAerosolDusterProductsPetitionCP21_​1.pdf?​VersionId=​nQcgEM4wvCJE97zmhwYCdAkwuluYerIt .

6.  The Commission voted 5-0 to publish this proposed rule.

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.   https://patentcenter.uspto.gov/​applications/​13848372 .

10.   www.cpsc.gov/​s3fs-public/​Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?​VersionId=​.NohA6DG6WsXh_​tsjhGuA7RuqMCOvxSW .

11.   www.cpsc.gov/​s3fs-public/​Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?​VersionId=​.NohA6DG6WsXh_​tsjhGuA7RuqMCOvxSW , 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: https://youtu.be/​FjlazUNE2-8?​si=​WsA4nfSbLX_​jJ2SR&​t=​40 . This reference video shows that the euphoric/high effects appear to occur with a single trigger pull of five seconds.

13.  Aerosol Duster Supporting Database, August 2023. ( https://www.cpsc.gov/​content/​Aerosol-Duster-Supporting-Database ).

14.   www.cpsc.gov/​s3fs-public/​Petition-Requesting-Rulemaking-to-Establish-Safety-Standard-for-Aerosol-Duster-Products-Petition-CP-21-1.pdf?​VersionId=​.NohA6DG6WsXh_​tsjhGuA7RuqMCOvxSW .

15.  See nida.nih.gov/publications/research-reports/inhalants/what-are-inhalants.

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.

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.

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.

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.

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.

34.  More information about the NEISS sample and estimate calculation can be found here: Explanation Of NEISS Estimates Obtained Through The CPSC website | CPSC.gov.

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.

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: www.fda.gov/​regulatory-information/​search-fda-guidance-documents/​estimating-maximum-safe-starting-dose-initial-clinical-trials-therapeutics-adult-healthy-volunteers .

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.

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; https://stacks.cdc.gov/​view/​cdc/​100478 .

40.   www.cpsc.gov/​s3fs-public/​Petition-Requesting-Rulemaking-to-Establish-Safety-Standard_​0.pdf?​VersionId=​GNEl7pYZUBOxf1BLSC0f4.X6TlA8gT4f .

41.   https://cpsc.gov/​s3fs-public/​Briefing-Package-Draft-Proposed-Rule-Aerosol-Duster-Products.pdf?​VersionId=​m8a.WZmo3DJvX0U3qR.EbOr4yQU9yeps .

42.   https://cpsc.gov/​s3fs-public/​Briefing-Package-Draft-Proposed-Rule-Aerosol-Duster-Products.pdf?​VersionId=​m8a.WZmo3DJvX0U3qR.EbOr4yQU9yeps .

43.  Maia Research (January 2024). United States Air Duster Industry Market Research Report. 2025 price estimate, deflated to 2023 dollars using CPI.

44.   www.cpsc.gov/​content/​Aerosol-Duster-Study-Final-Report .

45.   www.cpsc.gov/​s3fs-public/​Petition-Requesting-Rulemaking-to-Establish-Safety-Standard_​0.pdf?​VersionId=​GNEl7pYZUBOxf1BLSC0f4.X6TlA8gT4f .

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. ( https://www.cpsc.gov/​s3fs-public/​Aerosol-Duster-Study-2023-Redacted.pdf?​VersionId=​idRW1RnIfr_​5Jkc9sA9mkss8kTyUmZDD ).

47.  Small Business Administration, Table of Size Standards ( https://www.sba.gov/​document/​support-table-size-standards ).

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.

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: https://www.bls.gov/​news.release/​archives/​ecec_​03132024.pdf .

[ FR Doc. 2024-16716 Filed 7-30-24; 8:45 am]

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