Air programs: Stratospheric ozone protection— New alternatives policy program; unacceptable refrigerents; listing,

[Federal Register: January 26, 1999 (Volume 64, Number 16)]

[Rules and Regulations]

[Page 3861-3865]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr26ja99-26]

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 82

[FRL-6224-6]

RIN 2060-AG12

Protection of Stratospheric Ozone: Listing MT-31 as an Unacceptable Refrigerant Under EPA's Significant New Alternatives Policy (SNAP) Program

AGENCY: Environmental Protection Agency (EPA).

ACTION: Interim final rule.

SUMMARY: With this action, EPA's Significant New Alternatives Policy (SNAP) program lists as unacceptable for all refrigeration and air- conditioning end-uses the refrigerant blend known by the trade name MT- 31. This refrigerant blend was previously listed as an acceptable substitute for CFC-12 and HCFC-22 in various end-uses within the refrigerant and air-conditioning sector. After June 3, 1997, the date on which EPA published the Notice of Acceptability that listed MT-31 as acceptable, EPA became aware of toxicity data concerning one of the chemicals contained in the MT-31 blend that present significant concerns about risks to human health that may arise as a result of the use of this chemical, either alone or in a blend, in the refrigeration and air-conditioning sector. Today, therefore, EPA is removing MT-31 from the list of acceptable substitutes, and is listing MT-31 as unacceptable in all refrigeration and air-conditioning end-uses.

DATES: Effective Date: This action is effective Janaury 26, 1999. Comments: EPA will consider all written comments received by February 25, 1999 to determine whether any change to this action is necessary.

ADDRESSES: Information relevant to this notice is contained in Air Docket A-91-42, Central Docket Section, South Conference Room 4, U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, D.C. 20460, telephone: (202) 260-7548. The docket may be inspected between 8:00 a.m. and 5:30 p.m. weekdays. As provided in 40 CFR Part 2, a reasonable fee may be charged for photocopying. Those wishing to notify EPA of their intent to submit adverse comments on this action should contact Kelly Davis, U.S. EPA, Stratospheric Protection Division, Office of Atmospheric Programs, Office of Air and Radiation (6205-J), 401 M Street, S.W., Washington, DC 20460, (Docket # A-91-42), (202)- 564-2303.

FOR FURTHER INFORMATION CONTACT: Kelly Davis, U.S. EPA, Stratospheric Protection Division, Office of Atmospheric Programs, Office of Air and Radiation (6205-J), 401 M Street, S.W., Washington, DC, 20460, (202)- 564-2303 or electronically at davis.kelly@epa.gov. General information about EPA's SNAP program can be found by calling EPA's Stratospheric Ozone Protection Hotline at (800) 296-1996 or by viewing EPA's SNAP Program world wide web site at www.epa.gov/ozone/title6/snap/snap.html.

SUPPLEMENTARY INFORMATION:

Table of Contents

1. Section 612 Program

   1. Statutory Requirements

   2. Regulatory History Background

   3. Listing of Substitutes

   4. Necessity for Interim Final Rule II. Listing of MT-31 as Unacceptable III. Summary of Supporting Analyses

   1. Unfunded Mandates Reform Act and Regulatory Flexibility Act

   2. Executive Order 12866: Review of Significant Regulatory Actions by OMB

   3. Paperwork Reduction Act

   4. Executive Order 12875: Enhancing Intergovernmental Partnerships

   5. Submission to Congress and the General Accounting Office

   6. Executive Order 13045: Children's Health Protection

   7. Executive Order 13084: Consultation and Coordination With Indian Tribal Governments IV. Additional Information

1. Section 612 Program

   1. Statutory Requirements

      Section 612 of the Clean Air Act authorizes 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:

      ‹bullet› Rulemaking--Section 612(c) requires EPA to promulgate rules making it unlawful to replace any class I (chlorofluorocarbon, halon, carbon tetrachloride, methyl chloroform, methyl bromide, and hydrobromofluorocarbon) or class II (hydrochlorofluorocarbon) substance with any substitute that the Administrator determines may present adverse effects to human health or the environment where the Administrator has identified an alternative that (1) reduces the overall risk to human health and the environment, and (2) is currently or potentially available.

      ‹bullet› Listing of Unacceptable/Acceptable Substitutes--Section 612(c) also requires EPA to publish a list of the substitutes unacceptable for specific uses. EPA must publish a corresponding list of acceptable alternatives for specific uses.

      ‹bullet› Petition Process--Section 612(d) grants the right to any person to petition EPA to add a substance to or delete a substance from the lists published in accordance with section 612(c). The Agency has 90 days to grant or deny a petition. Where the Agency grants the petition, EPA must publish the revised lists within an additional six months.

      ‹bullet› 90-day Notification--Section 612(e) requires EPA to require any person who produces a chemical substitute for a class I substance to notify the Agency not less than 90 days before new or existing chemicals are introduced into

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      interstate commerce for significant new uses as substitutes for a class I substance. The producer must also provide the Agency with the producer's unpublished health and safety studies on such substitutes.

      ‹bullet› Outreach--Section 612(b)(1) states that the Administrator shall seek to maximize the use of federal research facilities and resources to assist users of class I and II substances in identifying and developing alternatives to the use of such substances in key commercial applications.

      ‹bullet› Clearinghouse--Section 612(b)(4) requires the Agency to set up a public clearinghouse of alternative chemicals, product substitutes, and alternative manufacturing processes that are available for products and manufacturing processes which use class I and II substances.

   2. Regulatory History Background

      On March 18, 1994, EPA published the Final SNAP Rule (59 FR 13044) which described the process for administering the SNAP program and issued EPA's first acceptability lists for substitutes in the major industrial use sectors. These sectors include: refrigeration and air conditioning; foam blowing; solvent cleaning; fire suppression and explosion protection; sterilants; aerosols; adhesives, coatings and inks; and tobacco expansion. These sectors compose the principal industrial sectors that historically consumed the largest volumes of ozone-depleting compounds.

      The Agency defines a ``substitute'' as any chemical, product substitute, or alternative manufacturing process, whether existing or new, that could replace a class I or class II substance. Anyone who produces a substitute must provide the Agency with health and safety studies on the substitute at least 90 days before introducing it into interstate commerce for significant new use as an alternative. This requirement applies to chemical manufacturers, but may include importers, formulators or end-users when they are responsible for introducing a substitute into commerce.

   3. Listing of Substitutes

      To develop the lists of unacceptable and acceptable substitutes, EPA conducts screens of health and environmental risks posed by various substitutes for ozone-depleting compounds in each use sector. The outcome of these risk screens can be found in the public docket.

      Under section 612, the Agency has considerable discretion in the risk management decisions it can make under the SNAP program. The Agency has identified five possible decision categories: acceptable, acceptable subject to use conditions; acceptable subject to narrowed use limits; unacceptable; and pending. Acceptable substitutes can be used for all applications within the relevant sector end-use. Conversely, it is illegal to replace an ozone-depleting substitute with a substitute listed by SNAP as unacceptable for that end-use. A pending listing represents substitutes for which the Agency has not received complete data or has not completed its review of the data.

      After reviewing a substitute, the Agency may make a determination that a substitute is acceptable only if certain conditions of use are met to minimize risks to human health and the environment. Such substitutes are described as ``acceptable subject to use conditions.'' Use of such substitutes without meeting associated use conditions renders these substitutes unacceptable and subjects the user to enforcement for violation of section 612 of the Clean Air Act.

      Even though the Agency can restrict the use of a substitute based on the potential for adverse effects, it may be necessary to permit a narrowed range of use within a sector end-use because of the lack of alternatives for specialized applications. Users intending to adopt a substitute acceptable with narrowed use limits must ascertain that other acceptable alternatives are not technically feasible. Companies must document the results of their evaluation, and retain the results on file for the purpose of demonstrating compliance. This documentation shall include descriptions of substitutes examined and rejected, processes or products in which the substitute is needed, reason for rejection of other alternatives, e.g., performance, technical or safety standards, and the anticipated date other substitutes will be available and projected time for switching to other available substitutes. Use of such substitutes in applications and end-uses which are not specified as acceptable in the narrowed use limit renders these substitutes unacceptable.

      As described in the Final SNAP Rule, EPA does not believe that rulemaking procedures are required to list alternatives that are determined to be acceptable with no limitations. Such listings do not impose any sanction, nor do they remove any prior license to use a substitute. Consequently, EPA periodically adds substitutes to the list of acceptable alternatives without first requesting comment on new listings. Updates to the acceptable and pending lists are published in separate Notices in the Federal Register.

      Also as described in the Final SNAP Rule, EPA believes that notice- and-comment rulemaking is required to place any alternative on the list of prohibited substitutes, to list a substitute as acceptable only under certain use conditions or narrowed use limits, or to remove an alternative from either the list of prohibited or acceptable substitutes. In this interim final rule, however, EPA is removing an alternative from lists of acceptable substitutes for CFC-12 and HCFC-22 refrigerants, and is listing MT-31 as unacceptable in all refrigeration and air-conditioning end-uses, without prior notice and comment. The reasons for the Agency's decision to do so in an interim final rule rather than in a notice-and-comment rulemaking are discussed in section D below.

   4. Necessity for Interim Final Rule

      Section 307(d)(3) of the Clean Air Act (CAA or the Act) states that in the case of any rule to which section 307(d) applies, notice of proposed rulemaking must be published in the Federal Register. The promulgation or revision of regulations under Title VI of the CAA (relating to stratospheric ozone protection) is generally subject to section 307(d). However, section 307(d) does not apply to any rule referred to in subparagraphs (A) or (B) of section 553(b) of the Administrative Procedure Act (APA), 5 U.S.C. 551 et seq.

      APA section 553(b) requires that any rule to which it applies be issued only after the public has received notice of, and an opportunity to comment on, the rule. However, APA section 553(b)(B) exempts from those requirements any rule for which the issuing agency for good cause finds that providing prior notice-and-comment would be impracticable, unnecessary or contrary to the public interest. Thus, any rule for which EPA makes such a finding is exempt from the notice-and-comment requirements of both APA section 553(b) and CAA section 307(d).

      EPA believes that the circumstances presented here provide good cause to take the actions set forth in this final rule without prior notice and comment, since providing prior notice and comment would be impracticable and contrary to the public interest. Specifically, EPA is concerned about health risks to workers associated with the use in replacement refrigerant formulations of one of the chemicals found in MT-31, in light of toxicity data regarding this chemical. EPA became aware of these data only after the Agency listed MT-31 as an acceptable

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      replacement refrigerant. Due to the fact that the manufacturer of MT-31 has claimed confidentiality with respect to the chemical composition of MT-31, EPA is unable to identify in this interim final rule which chemical in MT-31 is the subject of the Agency's concerns.

      The toxicity data indicate that typical worker exposure levels for the MT-31 chemical exceed minimal levels of concern for noncancer risks. Exposures to this chemical have been shown to lead to kidney damage. The Agency has conducted an exposure analysis to determine probable exposure concentrations of MT-31 in occupational settings. The Agency has determined that when this chemical is used as a refrigerant or as a component in a refrigerant blend, persons who manufacture, service or dispose of refrigeration and air-conditioning equipment that contains MT-31 may be exposed to levels of this chemical that put them at risk of kidney damage, particularly if they have not been specifically trained in the handling of this chemical or of blends containing this chemical. The Agency, moreover, is aware that MT-31 is currently commercially available, and is being used as a refrigerant, in multiple end-uses (e.g., airport air-conditioning systems, ice machines and bus air-conditioning), in multiple commercial locations throughout the nation. EPA believes that persons servicing or disposing of the refrigeration and air-conditioning units in these locations are subject to a real threat of exposure and consequently, to an actual and immediate health risk. Therefore, the Agency believes that good cause exists to take the actions set forth in this final rule without prior notice and comment

      As stated in section 612(c) of the Act, one of the Agency's objectives in implementing the SNAP program is to promulgate rules making it unlawful to replace any class I or class II substance with any substitute that EPA determines may present adverse effects to human health or the environment. The Agency believes that the chemical composition of MT-31 presents an unacceptable risk to human health, and that immediate action by EPA is necessary in order to avoid any resulting harm. The use of MT-31 in the refrigeration and air- conditioning sector will come to a halt most quickly through the publication of this interim final rule. In addition, this action, combined with Agency outreach and communication efforts, should provide any current or potential users of MT-31 with immediate notice that EPA does not consider MT-31 to be an appropriate compound to use in the refrigeration and air-conditioning sector, and that potential health risks are associated with exposure to MT-31 during the manufacture and servicing of any refrigeration and air-conditioning equipment that contains MT-31. A full notice-and-comment rulemaking would defeat the regulatory objective of the SNAP program to fully ensure protection of human health.

      Nonetheless, EPA is providing 30 days for submission of public comments following today's action. EPA will consider all written comments submitted in the allotted time period to determine if any change to this action is necessary.

      Section 553(d) of the APA generally provides that rules may not take effect earlier than 30 days after they are published in the Federal Register. However, if an Agency identifies a good cause, APA section 553(d)(3) allows a rule to take effect earlier, provided that the Agency publishes its reasoning in the final rule. Since EPA has determined that good cause exists to remove MT-31 from the lists of replacement refrigerants acceptable under the SNAP program, and list it instead as unacceptable as a replacement refrigerant, EPA is making this action immediately effective in order to ensure the fullest protection of human health.

2. Listing of MT-31 as Unacceptable

   EPA originally listed MT-31 as an acceptable replacement refrigerant in a Notice of Acceptability published at 62 FR 30275 on June 3, 1997. In that Notice, EPA specifically listed MT-31 as acceptable as a substitute for CFC-12 in the following retrofitted and new systems:

   ‹bullet› Centrifugal and Reciprocating Chillers

   ‹bullet› Industrial Process Refrigeration

   ‹bullet› Cold Storage Warehouses

   ‹bullet› Refrigerated Transport

   ‹bullet› Retail Food Refrigeration

   ‹bullet› Vending Machines

   ‹bullet› Water Coolers

   ‹bullet› Commercial Ice Machines

   ‹bullet› Household Refrigerators

   ‹bullet› Household Freezers

   and as a substitute for HCFC-22 in all retrofitted end-uses. EPA stated in the Notice that ``[t]his blend does not contain any flammable components, and all components are low in toxicity.''

   As noted above, however, in light of information recently reviewed by EPA concerning the toxicity of one of the chemicals contained in MT- 31, EPA now is greatly concerned about this chemical in replacement refrigerant formulations. Due to the fact that the manufacturer of MT- 31 has claimed confidentiality with respect to the chemical composition of MT-31, EPA is unable to identify in this interim final rule which chemical is the subject of the Agency's concerns.

   EPA has completed a risk screen for this chemical which indicates that the use of MT-31 in the refrigeration and air-conditioning end- uses listed above is unacceptable because of the significant health concerns associated with these uses of the chemical contained in MT-31. (Note that a risk screen for the components of MT-31 is not located in the docket because the manufacturer of MT-31 has claimed confidentiality with respect to the chemical composition of MT-31.) In particular, EPA's risk screen indicates that MT-31 will pose a risk to anyone exposed to the chemical during the manufacture or servicing of refrigeration or air-conditioning equipment that uses refrigerant that contains this chemical. Because of the extremely low occupational exposure limit for the chemical, and the fact that worker exposure levels for the chemical were predicted to be above levels of concern for noncancer risks, this chemical, and therefore MT-31, should not be used in the refrigeration and air conditioning sector. It should be noted that today's determination has no bearing on the use of MT-31 other than as a replacement for a class I or class II substance in the refrigeration and air-conditioning sector. Other industrial sectors may have safeguards in place to protect against worker exposure to MT-31. Based on the review of the available toxicity information related to this chemical, and the results of the EPA risk screen, EPA is today listing MT-31 as unacceptable for all refrigeration and air- conditioning end-uses, whether as a substitute for a class I substance such as CFC-12, or as a substitute for a class II substance such as HCFC-22.

3. Summary of Supporting Analyses

   1. Unfunded Mandates Reform Act and Regulatory Flexibility Act

      Since this action is not subject to notice-and-comment rulemaking requirements under the APA or any other law, it is also not subject to sections 202, 204 or 205 of the Unfunded Mandates Reform Act (UMRA). In addition, since this action does not impose annual costs of $100 million or more on small governments or uniquely affect small governments, the Agency has no obligations under section 203 of UMRA. Moreover, since this action is not subject to notice-and-comment requirements under the APA or any other statute as stated above, it is not subject to section 603 or 604 of the Regulatory Flexibility Act.

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   2. Executive Order 12866: Review of Significant Regulatory Actions by OMB

      Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether this regulatory action is ``significant'' and therefore subject to Office of Management and Budget (OMB) review and the requirements of the Executive Order. The Order defines ``significant'' regulatory action as one that is likely to result in a rule that may:

      (1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

      (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

      (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

      (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.

      OMB has determined that this rule is not a ``significant regulatory action'' within the meaning of the Executive Order.

   3. Paperwork Reduction Act

      EPA has determined that this final rule contains no information requirements subject to the Paperwork Reduction Act, 44 U.S.C. 3501 et seq., that are not already approved by the Office of Management and Budget (OMB). OMB has reviewed and approved two Information Collection Requests by EPA which are described in the March 18, 1994 rulemaking (59 FR 13044, at 13121, 13146-13147) and in the October 16, 1996 rulemaking (61 FR 54030, at 54038-54039). The OMB Control Numbers are 2060-0226 and 2060-0350.

   4. Executive Order 12875: Enhancing Intergovernmental Partnerships

      Under Executive Order 12875, EPA may not issue a regulation that is not required by statute and that creates a mandate upon a State, local or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 12875 requires EPA to provide to the Office of Management and Budget a description of the extent of EPA's prior consultation with representatives of affected State, local and tribal governments, the nature of their concerns, copies of any written communications from the governments, and a statement supporting the need to issue the regulation. In addition, Executive Order 12875 requires EPA to develop an effective process permitting elected officials and other representatives of State, local and tribal governments ``to provide meaningful and timely input in the development of regulatory proposals containing significant unfunded mandates.''

      Today's rule does not create a mandate upon any State, local, or tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 1(a) of Executive Order 12875 do not apply to this rule.

   5. Submission to Congress and the General Accounting Office

      Under 5 U.S.C. 801(a)(1)(A) as added by the Small Business Regulatory Enforcement Fairness Act of 1996, EPA submitted 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 General Accounting Office prior to publication of the rule in today's Federal Register. This rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

   6. Executive Order 13045: Children's Health Protection

      This final rule is not subject to E.O. 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because it does not involve decisions on environmental health risks or safety risks that may disproportionately affect children.

   7. Executive Order 13084: Consultation and Coordination With Indian Tribal Governments

      Under Executive Order 13084, EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments, or EPA consults with those governments. If EPA complies by consulting, Executive Order 13084 requires EPA to provide to the Office of Management and Budget, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected officials and other representatives of Indian tribal governments ``to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.''

      Today's rule does not significantly or uniquely affect the communities of Indian tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this rule.

   8. National Technology Transfer and Advancement Act

      The National Technology Transfer and Advancement Act of 1995 (NTTAA), Sec. 12(d), Pub. L. 104-113, requires federal agencies and departments to use the technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments. If use of such technical standards is inconsistent with applicable law or otherwise impractical, a federal agency or department may elect to use technical standards that are not developed or adopted by voluntary consensus standards bodies if the head of the agency or department transmits to the Office of Management and Budget an explanation of the reasons for using such standards.

      This proposed rule does not mandate the use of any technical standards; accordingly, the NTTAA does not apply to this rule.

4. Additional Information

   For copies of the comprehensive SNAP lists or additional information on SNAP, contact the Stratospheric Protection Hotline at 1- 800-296-1996, Monday-Friday, between the hours of 10:00 a.m. and 4:00 p.m., Eastern Time.

   For more information on the Agency's process for administering the SNAP program or criteria for evaluation of substitutes, refer to the SNAP final rule published in the Federal Register on March 18, 1994 (59 FR 13044). Notices and rules published under the SNAP program, as well as EPA publications on protection of atmospheric ozone, are available from EPA's Ozone World Wide Web site at http://www.epa.gov/ozone/

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   title6/snap, and from the Stratospheric Protection Hotline number listed above.

   List of Subjects in 40 CFR Part 82

   Environmental protection, Administrative practice and procedure, Air pollution control, Reporting and recordkeeping requirements.

   Dated: January 19, 1999. Carol M. Browner, Administrator.

   40 CFR Part 82 is amended as follows:

   PART 82--PROTECTION OF STRATOSPHERIC OZONE

   1. The authority citation for part 82 continues to read as follows:

      Authority: 42 U.S.C. Sec. 7414, 7601, 7671-7671q.

   2. Subpart G is amended by adding Appendix E to read as follows:

      Subpart G--Significant New Alternatives Policy Program

      * * * * *

      Appendix E to Subpart G--Unacceptable Substitutes Listed in the Janaury 26, 1999 Final Rule, Effective Janaury 26, 1999

      Refrigeration and Air-Conditioning Sector Unacceptable Substitutes

      End-use

      Substitute

      Decision

      Comments

      All refrigeration and air-

      MT-31 Unacceptable.......... Chemical contained in this blend conditioning end uses.

      presents unacceptable toxicity risk.

      [FR Doc. 99-1764Filed1-25-99; 8:45 am]

      BILLING CODE 6560-50-P