Environmental Protection Agency (EPA).
Final rule.
Pursuant to the U.S. Environmental Protection Agency's Significant New Alternatives Policy program, this action lists C7 Fluoroketone as an acceptable substitute, subject to narrowed use limits, for ozone-depleting substances used as streaming agents in the fire suppression and explosion protection sector. The program implements Section 612 of the Clean Air Act, as amended in 1990, which requires the Agency to evaluate substitutes and find them acceptable where they pose comparable or lower overall risk to human health and the environment than other available substitutes.
This rule is effective on May 29, 2013.
EPA has established a docket for this action under Docket ID No. EPA–HQ–OAR–2011–0111. All documents in the docket are listed on the
Bella Maranion, Stratospheric Protection Division, Office of Atmospheric Programs (6205J), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 343–9749; fax number: (202) 343–2363; email address:
The regulations implementing the Significant New Alternatives Policy (SNAP) program are codified at 40 CFR part 82, subpart G. The appendices to subpart G list substitutes for ozone-depleting substances (ODSs) for specific end uses as unacceptable or as acceptable with certain restrictions imposed on their use. In addition, a list of acceptable substitutes without restrictions is available at
This final rule finds C7 Fluoroketone acceptable subject to narrowed use limits as a substitute for halon 1211 for use as a streaming agent in portable fire extinguishers in nonresidential applications. Halons are chemicals that were once widely used in the fire protection sector but have been banned from production in the U.S. since 1994 because their emissions into the atmosphere are highly destructive to the stratospheric ozone layer. This action will provide users that need specialized fire protection applications with more alternatives to the use of halons. Businesses that may be regulated, either through manufacturing, distribution, installation and servicing, or use of the fire suppression equipment containing the substitutes are listed in the table below:
Section 612 of the Clean Air Act (CAA) requires EPA to develop a program for evaluating alternatives to ozone-depleting substances. EPA refers to this program as the Significant New Alternatives Policy (SNAP) program. The major provisions of Section 612 are:
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On March 18, 1994, EPA published the original rulemaking (59 FR 13044) which established the process for administering the SNAP program and issued EPA's first lists identifying acceptable and unacceptable substitutes in the major industrial use sectors (subpart G of 40 CFR part 82). These sectors include: Refrigeration and air-conditioning; foam blowing; solvents cleaning; fire suppression and explosion protection; sterilants; aerosols; adhesives, coatings and inks; and tobacco expansion. These sectors comprise the principal industrial sectors that historically consumed the largest volumes of ODS.
Section 612 of the CAA requires EPA to list as acceptable those substitutes that do not present a significantly greater risk to human health and the environment as compared with other substitutes that are currently or potentially available.
Under the SNAP regulations, anyone who plans to market or produce a substitute to replace a class I substance or class II substance in one of the eight major industrial use sectors must provide notice to the Agency, including health and safety information on the substitute at least 90 days before introducing it into interstate commerce for significant new use as an alternative. 40 CFR 82.176(a). This requirement applies to the persons planning to introduce the substitute into interstate commerce,
The Agency has identified four possible decision categories for substitutes that are submitted for evaluation: acceptable; acceptable subject to use conditions; acceptable subject to narrowed use limits; and unacceptable
After reviewing a substitute, the Agency may determine that a substitute is acceptable only if certain conditions in the way that the substitute is used are met to minimize risks to human health and the environment. EPA describes such substitutes as “acceptable subject to use conditions.” Entities that use these substitutes without meeting the associated use conditions are in violation of EPA's SNAP regulations. 40 CFR 82.174(c).
For some substitutes, the Agency may permit a narrow range of use within an end-use or sector. For example, the Agency may limit the use of a substitute to certain end-uses or specific applications within an industry sector. EPA describes these substitutes as “acceptable subject to narrowed use limits.” A person using a substitute that is acceptable subject to narrowed use limits in applications and end-uses that are not consistent with the narrowed use limit is using the substitute in an unacceptable manner and is in violation of section 612 of the CAA and EPA's SNAP regulations. 40 CFR 82.174(c).
The Agency publishes its SNAP program decisions in the
In contrast, EPA publishes decisions concerning substitutes that are deemed acceptable with no restrictions in “notices of acceptability,” rather than as proposed and final rules. As described in the preamble to the rule initially implementing the SNAP program in the
Many SNAP listings include “Comments” or “Further Information” to provide additional information on substitutes. Since this additional information is not part of the regulatory decision, these statements are not binding for use of the substitute under the SNAP program. However, regulatory requirements so listed are binding under other regulatory programs (e.g., worker protection regulations promulgated by the U.S. Occupational Safety and Health Administration (OSHA)). The “Further Information” classification does not necessarily include all other legal obligations pertaining to the use of the substitute. While the items listed are not legally binding under the SNAP program, EPA encourages users of substitutes to apply all statements in the “Further Information” column in their use of the substitute. In many instances, the information simply refers to sound operating practices that have already been identified in existing industry and/or building codes and standards. Thus, many of the comments, if adopted, would not require the affected user to make significant changes in existing operating practices.
For copies of the comprehensive SNAP lists of substitutes or additional information on SNAP, refer to EPA's Ozone Layer Protection Web site at
Application: C7 Fluoroketone—Acceptable Subject to Narrowed Use Limits
C7 Fluoroketone is also known as C7 FK or FK–6–1–14. This substitute is a blend of two isomers, 3-pentanone,1,1,1,2,4,5,5,5-octafluoro-2,4-bis(trifluoromethyl) (Chemical Abstracts Service Registry Number [CAS Reg. No.] 813–44–5) and 3-hexanone,1,1,1,2,4,4,5,5,6,6,6-undecafluoro-2-(trifluoromethyl) (CAS Reg. No. 813–45–6). You may find the submission under docket EPA–HQ–OAR–2011–0111 at
The physicochemical properties of the majority of halon substitutes make it unlikely that the substitutes would be released to surface water as a result of use. In the case of C7 Fluoroketone, the proposed substitute is insoluble in water and readily volatilizes. Thus, EPA expects that all of the constituents would rapidly vaporize during expulsion from the container, would not be likely to settle, and therefore would be unlikely to lead to surface water contamination or generation of solid waste.
C7 Fluoroketone has not been exempted as a volatile organic compound (VOC) under the CAA (40 CFR 51.100(s)). VOC emissions from the production of portable extinguishers charged with C7 Fluoroketone are controlled through standard industry practices, and as such, emissions from manufacture of units are likely to be minimal. An assessment was performed to compare the annual VOC emissions from use of C7 Fluoroketone in portable extinguishers in one year to other anthropogenic sources of VOC emissions. This assessment is available in docket EPA–HQ–OAR–2011–0111 under the name, “Risk Screen on
EPA evaluated occupational and general population exposure at manufacture and at end use to ensure that the use of C7 Fluoroketone will not pose unacceptable risks to workers or the general public. This risk screen is available in docket EPA–HQ–OAR–2011–0111 under the name, “Risk Screen on Substitute for Halon 1211 as a Streaming Agent in Portable Fire Extinguishers Substitute: C7 Fluoroketone.”
EPA is providing the following additional information regarding use of C7 Fluoroketone as a streaming agent in nonresidential applications. Appropriate protective measures should be taken and proper training administered for the manufacture, clean-up and disposal of this product. For this new chemical, the manufacturer developed an acceptable exposure limit (AEL) for the workplace set at a level believed to protect from chronic adverse health effects those workers who are regularly exposed, such as in the manufacturing or filling processes. EPA reviewed the submitter's supporting data and accepts the manufacturer's AEL for C7 Fluoroketone of 225 ppm over an 8-hour time-weighted average.
EPA recommends that users of C7 Fluoroketone as a streaming agent act in accordance with the latest edition of NFPA Standard 10 for Portable Fire Extinguishers. We expect that users will be able to meet the recommended workplace exposure limit and address potential health risks by following the above recommendations, using the substitute in accordance with the manufacturer's MSDS, and following other safety precautions common to the fire protection industry.
The EPA published in the
In response to the above comment, the compound's manufacturer submitted a late comment disagreeing with these statements and indicating that hydrate formation is significantly different for branched fluoroketones such as C7 Fluoroketone compared to simple unbranched fluoroketones such as HFA. The manufacturer stated that C7 Fluoroketone has low mammalian toxicity, low potential for aquatic toxicity and low environmental impact.
Further, two inhalation studies performed for C7 Fluoroketone (a 5-day repeat toxicity study in which study animals were exposed to high concentrations of the compound and a 28-day repeat dose study in which male and female rats were exposed to concentrations ≤10,000 ppm for 6 hours per day) showed no inhalation portal-of-entry effects.
We are issuing a final listing for C7 Fluoroketone, finding it acceptable subject to narrowed use limits for use as a substitute for halon 1211 as a streaming agent in non-residential applications, as initially proposed. We have determined that the overall environmental and human health risk posed by C7 Fluoroketone is lower than or comparable to the risks posed by other available substitutes in the same end use.
This action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and it is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011).
This action does not impose any new information collection burden. This final rule is an Agency determination. It contains no new requirements for reporting. However, the Office of Management and Budget (OMB) has previously approved the information collection requirements contained in the existing regulations in subpart G of 40 CFR part 82 under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501 et seq. and has assigned OMB control numbers 2060–0226 (EPA ICR No. 1596.08). The OMB control numbers for EPA's regulations are listed in 40 CFR part 9.
The Regulatory Flexibility Act (RFA) generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statutes unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.
For purposes of assessing the impact of today's rule on small entities, small entities are defined as (1) a small business that produces or uses fire suppressants such as total flooding and/or streaming agents as defined by the Small Business Administration's regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of today's final rule on small entities, I certify that this action will not have a significant economic impact on a substantial number of small entities. This final rule will not impose any requirements on small entities beyond current industry practices. Today's action effectively supports the introduction of a new alternative to the market for fire protection extinguishing systems, thus providing additional options for users making the transition away from ozone-depleting halons.
Use of halon 1301 total flooding systems and halon 1211 streaming agents have historically been in specialty fire protection applications including essential electronics, civil aviation, military mobile weapon systems, oil and gas and other process industries, and merchant shipping with smaller segments of use including libraries, museums, and laboratories. The majority of halon system and equipment owners continue to maintain and refurbish existing systems since halon supplies continue to be available in the U.S. Owners of new facilities make up the market for the new alternative agent systems and may also consider employing other available fire protection options including new, improved technology for early warning and smoke detection. Thus, EPA is providing more options to any entity, including small entities, by finding substitutes acceptable for use. The narrowed use limit imposed on the substitute in today's rule is consistent with the application suggested by the submitter and with current industry practices. Therefore, we conclude that the rule does not impose any new cost on businesses.
Although this final rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this rule on small entities. By finding a new substitute acceptable, today's rule gives additional flexibility to small entities that are concerned with fire suppression. EPA also has worked closely together with the NFPA, which conducts regular outreach with small entities and involves small state, local, and tribal governments in developing and implementing relevant fire protection standards and codes.
This action contains no Federal mandates under the provisions of Title II of the Unfunded Mandate Reform Act of 1995 (UMRA), 2 U.S.C. 1531–1538 for State, local, or tribal governments or the private sector. This action imposes no enforceable duty on any State, local, or tribal governments or the private sector. Therefore, this action is not subject to the requirements of sections 202 or 205 of the UMRA.
This action is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. This final rule will provide an additional option for fire protection subject to safety guidelines in industry standards. These standards are typically already required by state or local fire codes, so this action will not affect small governments.
This action does not have federalism implications. It will not have substantial
This action does not have tribal implications, as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It does not significantly or uniquely affect the communities of Indian tribal governments because this regulation applies directly to facilities that use this substance and not to tribal or governmental entities. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to E.O. 13045 (62 FR 19885, April 23, 1997) because it is not economically significant as defined in E.O. 12866, and because the Agency does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This action's health and risk assessments are discussed in section II.
This action is not subject to Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104–113, 12(d) (15 U.S.C. 272 note) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards.
This rulemaking involves technical standards. EPA defers to existing NFPA voluntary consensus standards and Occupational Safety and Health Administration (OSHA) regulations that relate to the safe use of halon substitutes reviewed under SNAP. EPA has worked in consultation with OSHA to encourage development of technical standards to be adopted by voluntary consensus standards bodies. EPA refers users to the latest edition of NFPA 10 Standard for Portable Fire Extinguishers. A copy of this standard may be obtained by calling the NFPA's telephone number for ordering publications at 1–800–344–3555.
Executive Order (EO) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA has determined that this final rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it increases the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. This final rule provides a fire suppression substitute with no ODP and low GWP. The avoided ODS and greenhouse gas emissions would assist in restoring the stratospheric ozone layer, avoiding adverse climate impacts, and result in human health and environmental benefits.
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the
Environmental protection, Administrative practice and procedure, Air pollution control, Reporting and recordkeeping requirements, Stratospheric ozone layer.
For the reasons set out in the preamble, 40 CFR part 82 is amended as follows:
42 U.S.C. 7414, 7601, 7671–7671q.