98-31396. National Emission Standards for Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilization and Fumigation Operations  

  • [Federal Register Volume 63, Number 233 (Friday, December 4, 1998)]
    [Rules and Regulations]
    [Pages 66990-66994]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-31396]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 63
    
    [AD-FRL-6192-8]
    RIN 2060-AC28
    
    
    National Emission Standards for Hazardous Air Pollutants for 
    Ethylene Oxide Commercial Sterilization and Fumigation Operations
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Interim final rule.
    
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    SUMMARY: Today's action suspends the National Emission Standards for 
    Hazardous Air Pollutants for Ethylene Oxide Commercial Sterilization 
    and Fumigation Operations (EO NESHAP) requirements for chamber exhaust 
    and aeration room vents. The suspension allows affected sources subject 
    to the EO NESHAP to defer compliance with the NESHAP requirements for 
    chamber exhaust and aeration room vents for one year until December 6, 
    1999. This suspension does not affect the requirement for sources 
    subject to the EO NESHAP to comply with provisions for sterilizer vents 
    by December 6, 1998. This action does not change the level of the 
    standards or the intent of the NESHAP promulgated in 1994.
    
    DATES: This action is effective December 4, 1998.
        Comments may be submitted until January 4, 1999.
    
    ADDRESSES: Comments may be submitted to the Docket address which 
    follows. Docket No. A-88-03, category VIII Amendments, containing 
    information considered by the EPA in developing this rule, is available 
    for public inspection and copying between 8:00 a.m. and 5:30 p.m., 
    Monday through Friday, except for Federal holidays, at the EPA's Air 
    and Radiation Docket and Information Center, room M1500, U.S. EPA, 401 
    M Street, SW, Washington, DC 20460; telephone (202) 260-7548. A 
    reasonable fee may be charged for copying. This docket also contains 
    information considered by the EPA in proposing and promulgating the 
    original EO NESHAP.
    
    FOR FURTHER INFORMATION CONTACT: For information concerning 
    applicability and rule determinations, contact the appropriate EPA 
    regional or Office of Enforcement and Compliance Assurance (OECA) 
    representative:
    
    Region I: Susan Lancey, Air Programs Enforcement Office Chief, U.S. 
    EPA, Region I, JFK Federal Building (SEA), Boston, MA 02203-2211, PH: 
    (617) 565-3587 Fax: (617) 565-4940
    Region II: Umesh Dholakia, Air Compliance Branch Chief, U.S. EPA, 
    Region II, 290 Broadway, New York, NY 10007-1866, PH: (212) 637-4023, 
    Fax: (212) 637-3901
    Region III: Dianne Walker, U.S. EPA, Region III (3AT12), 841 Chestnut 
    Building, Philadelphia, PA 19107, PH: (215) 566-3297, Fax number (215) 
    566-2114
    Region IV: Lee Page, U.S. EPA, Region IV (AR-4), 100 Alabama Street, 
    SW, Atlanta, GA 30303-3104, PH: (404) 562-9131, Fax: (404) 562-9095
    Region V: Bruce Vainer (AE-17J), U.S. EPA, Region V, 77 W. Jackson 
    Blvd., Chicago, IL 60604, PH: (312) 886-6793, Fax: (312) 353-8289
    Region VI: Robert Todd (6PD-R), U.S. EPA, Region VI (6PD-R), 1445 Ross 
    Avenue, Suite 700, Dallas, TX 75202-2733, PH: (214) 665-2156, Fax: 
    (214) 665-7263
    Region VII: Richard Tripp, U.S. EPA, Region VII, 726 Minnesota Avenue, 
    Kansas City, KS 66101, PH: (913) 551-7566 Fax: (913) 551-7065
    Region VIII: Victoria Parker-Christensen, U.S. EPA, Region VIII (8P2-
    A), 999 18th Street, Suite 500, Denver, CO 80202-2405, PH: (303) 312-
    6441, Fax: (303) 312-6064
    Region IX: Mae Wang, U.S. EPA, Region IX (Air-4), 75 Hawthorne Street, 
    San Francisco, CA 94105, PH: (415) 744-1200 Fax: (415) 744-1076
    Region X: Andrea Wullenweber, Office of Air Quality (OAQ-107), U.S. 
    EPA, Region X, 1200 Sixth Avenue, Seattle, WA 98101-9797, PH: (206) 
    553-8760 Fax: (206) 553-0110
    OECA: Charlie Garlow, U.S. EPA, OECA (2242A), 401 M Street, SW, 
    Washington, DC 20460, PH: (202) 564-1088, Fax: (202) 564-0068.
    
        For information concerning the analyses performed in developing 
    this interim final rule, contact Mr. David Markwordt, Policy, Planning 
    and Standards Group, Emission Standards Division (MD-13), Office of Air 
    Quality Planning and Standards, U.S. EPA, Research Triangle Park, NC 
    27711, PH: (919) 541-0837 Fax: (919) 541-0942. For information 
    concerning the accident investigations, contact Mr. Craig Matthiessen, 
    Chemical Emergency Preparedness and Prevention Office (5101), Office of 
    Solid Waste and Emergency Response, U.S. EPA, 401 M Street, SW, 
    Washington, DC 20460, PH: (202) 260-9781 Fax: (202) 260 0927.
    
    SUPPLEMENTARY INFORMATION:
    
    Electronic Access
    
        An electronic version of this rule is available for downloading 
    from the EPA Technology Transfer Network (TTN) at ``http://www.epa.gov/
    ttn/oarpg/ramain.html.'' For assistance in downloading files, call the 
    TTN Help line at (919) 541-5384.
    
    Regulated Entities
    
        Regulated categories and entities include:
    
                   Table 1.--Regulated Categories and Entities
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                  Entity category                   Description/SIC code
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    Industrial................................  Medical suppliers/3841,
                                                 3842.
                                                Pharmaceuticals/2834, 5122,
                                                 2831, 2833.
                                                Spice manufactures/2099,
                                                 5149, 2034, 2035, 2046.
                                                Contract Sterilizers/7399,
                                                 7218, 8091.
    Federal Government                          Not Affected.
    State/Local/Tribal Gov                      Not Affected.
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        This table is not intended to be exhaustive, but rather provides a 
    guide for readers regarding entities regulated by the NESHAP addressed 
    in this interim final rule. If you have questions regarding the 
    applicability of the NESHAP addressed in this interim final rule to a 
    particular entity, consult the person listed in the preceding FOR 
    FURTHER INFORMATION section.
        The information presented in this preamble is organized as follows:
    
    I. Background and Summary of Action
    II. Summary of and Rationale for Suspension of Chamber Exhaust and 
    Aeration Room Vent Requirements
    III. Administrative Requirements
        A. Paperwork Reduction Act
        B. Executive Order 12866--Regulatory Planning and Review
        C. Unfunded Mandates Reform Act
        D. Regulatory Flexibility Act
        E. Executive Order 13045--Protection of Children From 
    Environmental Health Risks and Safety Risks
        F. National Technology Transfer and Advancement Act
        G. Executive Order 12875--Enhancing the Intergovernmental 
    Partnerships
        H. Executive Order 13084--Consultation and Coordination With 
    Indian Tribal Governments
        I. Submission to Congress and the Comptroller General
        J. Petitions for Judicial Review
    
    [[Page 66991]]
    
    I. Background and Summary of Action
    
        On December 6, 1994 (59 FR 62585), the EPA promulgated the EO 
    NESHAP which regulates emissions of ethylene oxide from new and 
    existing commercial sterilization and fumigation operations using one 
    ton or more of EO per year. The regulated category and entities 
    affected by today's action are the sources described in 40 CFR 63.360. 
    That provision includes commercial operations using ethylene oxide as a 
    sterilant and fumigant in the production of medical equipment and 
    supplies, and in miscellaneous sterilization and fumigation operations 
    at both major and area sources. Note that this description is not 
    intended to be exhaustive but, rather, to provide a guide for readers 
    interested in this compliance extension. To determine whether your 
    facility is affected by today's action, you should carefully examine 
    the applicability criteria in 40 CFR 63.360 and the explanation 
    provided in this document. If you have questions about the 
    applicability of today's action to a particular entity, consult the 
    appropriate person listed in the preceding FOR FURTHER INFORMATION 
    CONTACT section.
        In July 1997, the Agency learned of reports of explosions at 
    ethylene oxide sterilization and fumigation facilities. EPA 
    subsequently suspended the EO NESHAP for one year until December 6, 
    1998 to provide time to determine the appropriate action necessary to 
    mitigate the cause of the explosions. 62 FR 64736
    
    II. Summary of and Rationale for Suspension of Chamber Exhaust and 
    Aeration Room Vent Requirements
    
        As noted above, in July 1997, the Agency learned of reports of 
    explosions at ethylene oxide facilities. Several of these explosions 
    occurred at facilities subject to the EO NESHAP. The Agency immediately 
    began conducting a preliminary investigation to determine if the 
    emission control equipment mandated by 40 CFR part 63, Subpart O was in 
    any way associated with the cause of the problems at these facilities. 
    The Agency, on December 9, 1997, wishing to adopt a cautious approach 
    in order to assure public and worker safety, published in the Federal 
    Register an interim final rule suspending 40 CFR Part 63, Subpart O. 62 
    FR 64736. Since publication of the December 9, 1997 rule, both EPA and 
    industry have continued to investigate the cause of the accidents.
        In a June 2, 1998 letter to the Agency, the Ethylene Oxide 
    Sterilization Association (EOSA) recommended, ``additional time to 
    consider safe and economical control, installation, operation and 
    maintenance alternatives applicable to aeration and chamber exhaust 
    (backvent) emissions . . . ``(see Docket No. A-88-03, Item No. VIII-D-
    2). The Health Industries Manufacturers Association (HIMA) reviewed the 
    recommendation. EOSA and HIMA membership represent most of the ethylene 
    oxide sterilization and fumigation industry. EOSA ``concluded that the 
    oxidizer systems had not been properly integrated with traditional EtO 
    sterilization process operations, that is, installation, operation and 
    maintenance issues had not been sufficiently addressed by sterilizer 
    operators.'' EOSA also concluded that ``improperly overfeeding the 
    oxidizer system from the chamber backvent was the primary safety 
    concern.''
        The Agency also conducted an independent investigation of the 
    accidents and reviewed reports prepared by EPA Regional Offices and by 
    EOSA member sterilization companies and, based on that investigation 
    and review, concurred with the industry conclusion and recommendation 
    quoted above (see Docket No. A-88-03, Item No. VIII-B-1). The Agency 
    agrees that, in the cases where explosions occurred, the catalytic 
    oxidizer units were overfed with ethylene oxide in concentrations above 
    the safe operations limit due to abnormal activation of the chamber 
    exhaust (backvent). Normally, EO rich effluent drawn (vented) from the 
    sterilizer chamber at low flow is metered or mechanically restricted 
    and diluted with air to prevent high concentrations of EO from entering 
    the emissions control unit. The much greater backvent or chamber 
    exhaust flow, often in combination with aeration room exhaust, 
    generally is not restricted or diluted before entering the emissions 
    control unit. Aeration room concentrations typically are well below the 
    lower flammability limit for EO and the backvent is supposed to be 
    activated only when an extremely low concentration of EO is present in 
    the chamber during loading/unloading of products. Although all units 
    functioned as intended, the abnormal activation of the backvent at high 
    EO concentrations in the sterilization chamber led to the explosions. 
    The Agency also concludes main vent emissions routed through the vacuum 
    pump played no role in the explosions.
        The Agency also concludes that any emissions control technology 
    necessary to comply with this rule needs to be properly integrated into 
    the sterilization system and operations, and must reflect the full 
    range of normal and abnormal conditions that may occur. Investigations 
    and safety reviews, conducted independently by EPA and EOSA members, 
    confirmed that, as currently designed and operated, there still is a 
    possibility that backvents could be activated while high EO 
    concentrations are present in the sterilization chamber. Consequently, 
    sterilization chamber operators will need to further evaluate the 
    integration of the emission control technology with sterilizer 
    operation to ensure prevention of future explosions. Total system 
    safety issues can be addressed by conducting a comprehensive process 
    hazard analysis (PHA) for each sterilizer process and developing and 
    instituting safeguards that address these hazards. Additional time is 
    required to complete these analyses and install safeguards.
        In this matter, the Agency wishes to err, if at all, on the side of 
    safety. Accordingly, the Agency is today suspending the EO NESHAP 
    emission limitation requirements in 40 CFR Part 63, Subpart O, for 
    chamber exhaust and aeration room vents, as those emission points are 
    defined at 40 CFR 63.361, for one year, until December 6, 1999, 
    pursuant to EPA's general rulemaking authority under CAA Section 
    301(a), 42 U.S.C. 7601(a). Sources must comply with the EO NESHAP 
    emission limitation requirements in 40 CFR part 63, Subpart O, for 
    sterilization chamber vents, as those emission points are defined at 40 
    CFR 63.361 by December 6, 1998 because EPA has determined that they do 
    not pose a safety concern.
        CAA Section 301(a) grants the Administrator of the EPA the 
    authority ``to prescribe such regulations as are necessary to carry out 
    his functions under this Act.'' Given the unique circumstances and 
    uncertainty surrounding the EO NESHAP, as described in this document, 
    EPA believes that it is necessary to further suspend this rule's 
    requirements for chamber exhaust and aeration room vent for the safety 
    of the public and workers in and around EO facilities. As EOSA's and 
    EPA's investigations have shown, the control requirements of the EO 
    NESHAP for chamber exhaust and aeration room vents continue to pose 
    potential problems for which solutions are being developed. These 
    solutions include the redesign of control systems to prevent the 
    overfeeding of EO in concentrations above safe operating limits. The 
    EOSA is also exploring an alternative control strategy for back draft 
    vent emissions. This control approach does not require an abatement 
    device thus completely eliminating the possibility of overfeeding (see 
    Docket No. A-88-03, Items No.VIII-D-2 & 6).
    
    [[Page 66992]]
    
    The further extension provided in this document allows time for those 
    solutions to be perfected and finalized. This action is consistent with 
    the objectives of the Clean Air Act as stated in Section 101(b), 42 
    U.S.C. 7401(b). ``The purposes of this sub chapter are . . . to promote 
    the public health and welfare and the productive capacity of its 
    population. . . .''
        The original EO NESHAP and today's action are promulgated pursuant 
    to CAA Section 307(d), 42 U.S.C. 7607(d), which requires that any rule 
    subject to that section be issued only after the public has received 
    notice of, and an opportunity to comment on, the rule. However, Section 
    307(d)(1) exempts from those requirements any rule for which the Agency 
    finds under the Administrative Procedure Act, 5 U.S.C. 553(b), that 
    providing prior notice-and-comment would be impracticable, unnecessary 
    or contrary to the public interest.
        EPA believes the circumstances presented here provide good cause to 
    take this action without prior notice-and-comment. EPA finds that 
    providing prior notice-and-comment would be impracticable and contrary 
    to the public interest based on the potential ongoing danger to public 
    and worker safety posed by the recent incidents at ethylene oxide 
    facilities. There is simply not enough time to provide notice-and-
    comment procedures before the current compliance date of December 6, 
    1998 arrives, and until the compliance date is extended, sources are 
    faced with having to install control equipment in time to meet the 
    current compliance date. Only by omitting notice-and-comment from this 
    action can EPA provide sources affected by the EO NESHAP with timely 
    legal relief from the current compliance date, while EPA investigates 
    the situation. Consequently, this action is being promulgated without 
    prior notice-and-comment as provided for in CAA Section 307(b)(1) and 
    is effective December 4, 1998 as provided for in CAA Section 
    112(d)(10).
        Nonetheless, EPA is providing 30 days for submission of public 
    comments. EPA will consider all written comments submitted in the 
    allotted time period to determine if any change to this action is 
    necessary.
        In suspending the EO NESHAP requirements for chamber exhaust and 
    aeration room vents, the Administrator wishes to remind the public and 
    the regulated community that the role of the EPA has been and continues 
    to be protection of public health and the environment in a way that is 
    consistent with safety concerns.
    
    III. Administrative Requirements
    
    A. Paperwork Reduction Act
    
        The information collection requirements of the EO NESHAP were 
    submitted to and approved by the Office of Management and Budget (OMB). 
    A copy of this Information Collection Request (ICR) document (OMB 
    control number 2060-0283) may be obtained from Ms. Sandy Farmer, 
    Information Policy Branch (2136); U.S. EPA; 401 M Street, SW, 
    Washington, DC 20460, or by calling (202) 260-2740.
        Today's action has no impact on the information collection burden 
    estimates made previously. Today's action merely suspends the EO NESHAP 
    requirements for chamber exhaust and aeration room vents for one year. 
    This change does not impose new requirements. Consequently, the ICR has 
    not been revised.
    
    B. Executive Order 12866--Regulatory Planning and Review
    
        Under Executive Order 12866 (58 FR 51735, October 4, 1993), EPA 
    must determine whether the regulatory action is ``significant'' and, 
    therefore, subject to review by OMB on the basis of the requirements of 
    the Executive Order in addition to its normal review requirements. The 
    Executive 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.
        Today's action does not fall within any of the four categories 
    described above. Instead, it reduces the burden on certain sources by 
    temporarily suspending the EO NESHAP requirements for chamber exhaust 
    and aeration vents. Consequently, under Executive Order 12866, this 
    action is not a ``significant regulatory action'' and is, therefore, 
    not subject to review by the Office of Management and Budget.
    
    C. Unfunded Mandates Reform Act
    
        Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public 
    Law 104-4, establishes requirements for Federal agencies to assess the 
    effects of their regulatory actions on State, local, and tribal 
    governments and the private sector. Under Section 202 of the UMRA, EPA 
    generally must prepare a written statement, including a cost-benefit 
    analysis, for proposed and final rules with ``Federal mandates'' that 
    may result in expenditures to State, local, and tribal governments, in 
    the aggregate, or to the private sector of $100 million or more in any 
    one year. Before promulgating an EPA rule for which a written statement 
    is needed, Section 205 of the UMRA generally requires EPA to identify 
    and consider a reasonable number of regulatory alternatives and adopt 
    the least costly, most cost-effective or least burdensome alternative 
    that achieves the objects of the rule. The provisions of Section 205 do 
    not apply when they are inconsistent with applicable law. Moreover, 
    Section 205 allows EPA to adopt an alternative other than the least 
    costly, most cost-effective or least burdensome alternative if the 
    Administrator publishes with the final rule an explanation of why that 
    alternative was not adopted. Before EPA establishes any regulatory 
    requirements that may significantly or uniquely affect small 
    governments, including tribal governments, it must have developed under 
    Section 203 of the UMRA a small government agency plan. The plan must 
    provide for notifying potentially affected small governments, enabling 
    officials of affected small governments to have meaningful and timely 
    input in the development of EPA regulatory proposals with significant 
    Federal intergovernmental mandates, and informing, educating, and 
    advising small governments on compliance with the regulatory 
    requirements.
        Today's rule contains no Federal mandates (under the regulatory 
    provisions of Title II of the UMRA) for State, local, or tribal 
    governments or the private sector. Instead, this rule provides 
    additional time to comply with some requirements of the EO NESHAP. 
    Because the rule is not expected to result in the expenditure by State, 
    local, and tribal governments or the private sector of $100 million or 
    more in any one year, the Agency has not prepared a budgetary impact 
    statement or specifically addressed the selection of the least costly, 
    most effective, or least burdensome alternative. Because small 
    governments will not be significantly or uniquely affected by this 
    rule, the Agency is not required to develop a plan
    
    [[Page 66993]]
    
    with regard to small governments. For the reasons stated above, the 
    requirements of the UMRA do not apply to this section.
    
    D. Regulatory Flexibility Act
    
        Under the Regulatory Flexibility Act (or RFA), Public Law 96-354, 
    whenever an Agency publishes any proposed or final rule in the Federal 
    Register, it must, except under certain circumstances, prepare a 
    Regulatory Flexibility Analysis (RFA) that describes the impact of the 
    rule on small entities (i.e., small businesses, organizations, and 
    governmental jurisdictions). That analysis is not necessary if the 
    Agency certifies that the rule will not have a significant economic 
    impact on a substantial number of small entities.
        EPA believes that there will be little or no adverse impact on any 
    small entities as a result of the promulgation of this rule because, 
    rather than imposing additional requirements, this rule provides 
    additional time to comply with parts of the EO NESHAP. Because the 
    impacts are anticipated to be insignificant or beneficial, pursuant to 
    the provisions of 5 U.S.C. 605(b), I hereby certify that this rule will 
    not have a significant economic impact on a substantial number of small 
    entities. Consequently, an RFA is not required.
    
    E. Executive Order 13045--Protection of Children From Environmental 
    Health Risks and Safety Risks
    
        Executive Order 13045, entitled Protection of Children from 
    Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
    1997), applies to any rule that (1) OMB determines is ``economically 
    significant'' as defined under Executive Order 12866, and (2) EPA 
    determines the environmental health or safety risk addressed by the 
    rule has a disproportionate effect on children. If the regulatory 
    action meets both criteria, the Agency must evaluate the environmental 
    health or safety aspects of the planned rule on children, and explain 
    why the planned regulation is preferable to other potentially effective 
    and reasonably feasible alternatives considered by the Agency.
        This interim final rule is not subject to the Executive Order 
    because it is not economically significant as defined in E.O. 12866, 
    and because the Agency does not have reason to believe the 
    environmental health or safety risks addressed by this action present a 
    disproportionate risk to children.
    
    F. National Technology Transfer and Advancement Act
    
        Section 12 of the National Technology Transfer and Advancement Act 
    of 1995 (NTTAA) requires federal agencies to evaluate existing 
    technical standards when developing new regulations. To comply with the 
    NTTAA, EPA must consider and use ``voluntary consensus standards'' 
    (VCS) if available and applicable when developing programs and policies 
    unless doing so would be inconsistent with applicable law or otherwise 
    impractical.
        The EPA believes that the use of VCS in this interim final rule is 
    impractical. The suspension of the EO NESHAP requirements for chamber 
    exhaust and aeration room vents is merely a procedural action that does 
    not require sources to take substantive steps that lend themselves to 
    VCS.
    
    G. Executive Order 12875--Enhancing the Intergovernmental Partnership
    
        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 on State, local or tribal 
    governments. The rule does not impose any enforceable duties on these 
    entities. Rather, the rule temporarily suspends certain regulatory 
    requirements. Accordingly, the requirements of section 1(a) of 
    Executive Order 12875 do not apply to this rule.
    
    H. 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. This rule imposes no 
    enforceable duties on these entities. Rather, the rule temporarily 
    suspends certain regulatory requirements. Accordingly, the requirements 
    of section 3(b) of Executive Order 13084 do not apply to this rule.
    
    I. Submission to Congress and the Comptroller General
    
        The Congressional Review Act, 5 U.S.C. 801 et seq., as amended 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 Federal Register. A major rule 
    cannot take effect until 60 days after it is published in the Federal 
    Register. This action is not a ``major rule'' as defined by 5 U.S.C. 
    804(2). This rule will be effective December 4, 1998.
    
    J. Petitions for Judicial Review
    
        Under Section 307(b)(1) of the Clean Air Act (Act), judicial review 
    of this final action is available only by filing a petition for review 
    in the U.S. Court of
    
    [[Page 66994]]
    
    Appeals for the District of Columbia Circuit within 60 days of today's 
    publication of this interim final rule. Under Section 307(b)(2) of the 
    Act, the actions taken in today's document may not be challenged later 
    in civil or criminal proceedings brought by the EPA to enforce these 
    requirements.
    
    List of Subjects in 40 CFR Part 63
    
        Environmental protection, Air pollution control, Ethylene oxide 
    sterilization, Hazardous substances, Reporting and recordkeeping 
    requirements.
    
        Dated: November 18, 1998.
    Carol M. Browner,
    Administrator.
    
        For the reasons set out in the preamble, title 40, chapter I of the 
    Code of Federal Regulations is amended as follows:
    
    PART 63--[AMENDED]
    
        1. The authority citation for part 63 continues to read as follows:
    
        Authority: 42 U.S.C. 7401 et seq.
    
    Subpart O--[Amended]
    
        2. Section 63.360 is amended by revising paragraphs (g)(1), (g)(2), 
    and (g)(3) and adding paragraphs (g)(4), (g)(5), and (g)(6) to read as 
    follows:
    
    
    Sec. 63.360  Applicability.
    
    * * * * *
        (g) * * *
        (1) All sterilization chamber vents subject to the emissions 
    standards in Sec. 63.362 with an initial startup date before December 
    6, 1998, no later than December 6, 1998.
        (2) All sterilization chamber vents subject to the emissions 
    standards in Sec. 63.362 with an initial startup date on or after 
    December 6, 1998, immediately upon initial startup of the source.
        (3) All sterilization chamber vents at sources using less than 1 
    ton of ethylene oxide that increase their ethylene oxide usage after 
    December 6, 1998 such that the sterilization chamber vent becomes 
    subject to the emissions standards in Sec. 63.362(c), immediately upon 
    becoming subject to the emission standards.
        (4) All aeration room and chamber exhaust vents subject to the 
    emissions standards in Sec. 63.362 with an initial startup date before 
    December 6, 1999, no later than December 6, 1999.
        (5) All aeration room and chamber exhaust vents subject to the 
    emissions standards in Sec. 63.362 with an initial startup on or after 
    December 6, 1999, immediately upon initial startup of the source.
        (6) All aeration room and chamber exhaust vents at sources using 
    less than 10 tons of ethylene oxide that increase their ethylene oxide 
    usage after December 6, 1999 such that the aeration room and chamber 
    exhaust vents become subject to the emissions standards in 
    Sec. 63.362(d) and Sec. 63.362(e), immediately upon becoming subject to 
    the emission standards.
    
    [FR Doc. 98-31396 Filed 12-3-98; 8:45 am]
    BILLING CODE 6560-50-P
    
    
    

Document Information

Effective Date:
12/4/1998
Published:
12/04/1998
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Interim final rule.
Document Number:
98-31396
Dates:
This action is effective December 4, 1998.
Pages:
66990-66994 (5 pages)
Docket Numbers:
AD-FRL-6192-8
RINs:
2060-AC28
PDF File:
98-31396.pdf
CFR: (2)
40 CFR 63.362(d)
40 CFR 63.360