96-17549. Registration of Fuels and Fuel Additives: Minor Changes to the Testing Requirements for Registration  

  • [Federal Register Volume 61, Number 134 (Thursday, July 11, 1996)]
    [Rules and Regulations]
    [Pages 36506-36513]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-17549]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    40 CFR Part 79
    
    [FRL-5532-4]
    
    
    Registration of Fuels and Fuel Additives: Minor Changes to the 
    Testing Requirements for Registration
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Direct final rule.
    
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    [[Page 36507]]
    
    SUMMARY: The Environmental Protection Agency (``EPA'' or the 
    ``Agency'') is issuing, as a direct final rule, minor changes to the 
    health-effects testing requirements at 40 CFR Part 79, Subpart F. These 
    requirements deal with the exposure of animals to evaporate and exhaust 
    emissions from motor vehicles. The changes allow for increased 
    flexibility in engine selection, correct an inconsistency with respect 
    to mixing chamber quality assurance, establish clearer exposure timing 
    requirements, provide a necessary option for the units in which 
    emissions data are reported for heavy-duty vehicle engines, clarify 
    oxygen purity requirements, make some minor syntax changes, clarify the 
    handling of the measurements of background chemical species in the 
    ambient air used by the engine generating emissions, clarify the 
    driving schedules, clarify the exposure concentration requirements in 
    the inhalation chamber, clarify dilution system requirements, and 
    clarify the requirements for the collection of particulates and semi-
    volatiles. These changes will reduce the testing costs without 
    affecting the environmental objectives. This action is being taken 
    without prior notice because EPA believes that the minor changes in the 
    testing requirements will be noncontroversial.
        The rule implementing the testing requirements was finalized on May 
    27, 1994 (59 FR 33042, June 27, 1994). The test data will be used by 
    the Agency to determine if the emissions of certain gasolines and/or 
    diesel fuels present an unacceptable risk to public health. For 
    additional background information see the procedure in this issue of 
    the Federal Register proposing changes to the registration regulations. 
    The changes in this direct final rule have also been incorporated into 
    that notice of proposed rulemaking. If an adverse comment or a request 
    for a public hearing is received on this direct final rule, EPA will 
    withdraw the direct final rule and address the comment(s) in a 
    subsequent final rule based on the proposed rule.
    
    DATES: This action will be effective on August 26, 1996 unless EPA 
    receives an adverse comment or a request for a public hearing by August 
    12, 1996. If EPA receives an adverse comment or hearing request by that 
    date, EPA will withdraw this action via a document in the Federal 
    Register. All correspondence should be directed to the addresses below.
    
    ADDRESSES: Materials relevant to this rulemaking have been placed in 
    Docket A-90-07. The docket is located at the U.S. Environmental 
    Protection Agency, Air Docket Section (LE-131), 401 M Street, S.W., 
    Washington, DC 20460 in Room M-1500 of Waterside Mall. Documents may be 
    inspected between the hours of 8:00 a.m. and 5:30 p.m., Monday through 
    Friday. A reasonable fee may be charged for copying. Those wishing to 
    notify EPA of their intent to submit an adverse comment or request a 
    public hearing should contact Joseph Fernandes (202) 233-9756 or Jim 
    Caldwell (202) 233-9303 at the EPA.
    
    FOR FURTHER INFORMATION CONTACT: Joseph Fernandes (202) 233-9756 or Jim 
    Caldwell (202) 233-9303, USEPA, Office of Mobile Sources, Fuels and 
    Energy Division, Mail Code 6406J, 401 M Street, S.W., Washington, DC 
    20460.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Regulated Entities
    
        Regulated categories and entities potentially affected by this 
    action include:
    
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                                                    Examples of regulated   
                     Category                             entities          
    ------------------------------------------------------------------------
    Industry..................................  Manufacturers of gasoline   
                                                 and diesel fuel.           
                                                Manufacturers of additives  
                                                 for gasoline and diesel    
                                                 fuel.                      
    ------------------------------------------------------------------------
    
        This table is not intended to be exhaustive, but rather provides a 
    guide for readers regarding entities likely to be regulated by this 
    action. This table lists the types of entities that EPA is now aware 
    could be potentially regulated by this action. Other types of entities 
    not listed in the table could also be regulated. To determine whether 
    your entity would be regulated by this action, you should carefully 
    examine this preamble and the proposed changes to the regulatory text. 
    You should also carefully examine the existing provisions of the 
    registration program at 40 CFR part 79.
    
    II. Background
    
        For program background, see the notice in this issue of the Federal 
    Register proposing non-minor changes to the registration regulations 
    for fuels and fuel additives (F/FA). The changes to the testing 
    requirements in this direct final rule are minor and noncontroversial.
    
    III. Requirements for New Vehicles/Engines
    
        To ensure that the tests conducted on the emissions of one F/FA are 
    not affected by ``carryover'' emissions from other F/FAs previously 
    used in the test vehicle, Sec. 79.57 of the registration regulations 
    requires that a new vehicle or engine be used in the testing of each F/
    FA. The regulations also recommend that one or more identical new 
    vehicles or engines be acquired as backup emission generators for each 
    F/FA.
        The regulated industry has commented to EPA that this requirement 
    is burdensome, expensive, and unnecessary. They argue that suitable 
    conditioning procedures can satisfactorily ``flush out'' the remnants 
    of one F/FA and its emissions, so that the same vehicle or engine can 
    be used in testing another F/FA without fear of carryover effects. If 
    this were permitted, a substantially smaller fleet of initial test 
    vehicles/engines might suffice for a given series of F/FAs. Also, a 
    relatively small number of additional vehicles could be acquired to 
    serve as shared backups for the testing of more than one F/FA.
        A previous technical communication 1 discussed in detail the 
    possibility of short-term and long-term carryover effects due to test 
    vehicles/engines being used for multiple F/FAs. It also described the 
    restrictions and procedural safeguards which could be adopted to 
    minimize potential carryover problems. Based on that earlier 
    discussion, EPA believes it is now appropriate to ease some of the 
    restrictions on test vehicle use in some circumstances.
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        \1\ 1. Memo to Docket A-90-07 from James D. Greaves, ``A 
    Preconditioning Cycle for Potential Use in the Fuels and Fuel 
    Additives Registration Program,'' 1992 (Docket Item II-B-8).
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        Under this revision, the requirement that only new vehicles be used 
    in the test program (specified in Sec. 79.57(a)(1)) has been retained, 
    since it would not be possible to know how, and with what range of F/FA 
    products, a vehicle had been operated in general use. However, it is 
    now acceptable for a single test vehicle or engine to be used 
    sequentially by different F/FA manufacturers for tests on different F/
    FAs, assuming that adequate documentation is furnished to demonstrate 
    that the test vehicle/engine had not been used for purposes other than 
    testing under this program and that such previous testing was 
    restricted to F/FA types (see below) for which such test vehicle 
    sharing was allowed. The responsibility for assuring the adequacy of 
    such documentation falls to the fuel manufacturer who secondarily 
    acquires the test vehicle.
        As discussed in the previously-cited technical memorandum, concerns 
    about possible long-term carryover effects arise primarily in regard to 
    ``atypical''
    
    [[Page 36508]]
    
    elements. Consistent with that discussion, EPA believes that the 
    current prohibition against using test vehicles/engines for more than 
    one F/FA should be retained in the case of atypical F/FAs. However, in 
    the case of F/FAs which belong to the same fuel family (as defined in 
    Sec. 79.56(e)(1)) and which contain no elements other than carbon, 
    hydrogen, oxygen, nitrogen, and sulfur, EPA believes that long-term 
    carryover effects are of minimal concern, and thus believes that it is 
    acceptable to permit test vehicles to be used for more than one such F/
    FA. Thus, for example, a given test vehicle/engine could be used in 
    testing base gasoline and one or more nonbaseline gasoline 
    formulations. A vehicle that had been used for baseline and/or 
    nonbaseline gasoline testing may be used in testing one a typical F/FA 
    formulation, but may not subsequently be used for additional baseline/
    nonbaseline F/FA testing nor for testing of other atypical F/FAs.
        To prevent short-term carryover effects, a preconditioning 
    procedure is required to ``flush out'' the remnants of a previously 
    tested F/FA and its emissions from a vehicle's fuel system, engine, 
    exhaust system, and emission control system, before that vehicle is 
    used in the testing of another F/FA. A suitable ``intermediate 
    preconditioning cycle'' was described in the technical memorandum cited 
    previously, and EPA has adopted this cycle, to prevent short-term 
    carryover effects between tested F/FAs. Section 79.52(b)(2) is revised 
    accordingly.
    
    IV. Mixing Chamber Quality Assurance
    
        The method specified in the F/FA program regulations for generating 
    combustion emissions to be used in biological testing 
    (Sec. 79.57(e)(2)) requires a mixing chamber or other apparatus to 
    smooth out the variability in emission concentrations related to 
    transient-cycle operations. As a quality assurance mechanism, 
    Sec. 79.57(e)(2)(iii)(C) states that this apparatus ``must function 
    such that the average concentration of total hydrocarbons leaving the 
    apparatus shall be within 10 percent of the average concentration of 
    hydrocarbons entering the chamber.'' EPA has noted that this language 
    is inconsistent with Sec. 79.57(e)(2)(iv)(C), which allows intentional 
    dilution of the exhaust stream to occur ``in the mixing chamber (and/or 
    after leaving the chamber) to achieve the desired biological exposure 
    concentrations.''
        To correct this inconsistency, the language in 
    Sec. 79.57(e)(2)(iii)(C) is changed to account for intentional exhaust 
    dilution. Specifically, the following phrase has been added to the end 
    of the provision cited above: ``* * *, taking into account any further 
    intentional dilution occurring in the apparatus pursuant to paragraph 
    (e)(2)(iv)(C) of this section.''
    
    V. Exposure Interruptions
    
        Section 79.57(e)(2)(vii) of the regulations specifies how long 
    biological exposures may be interrupted without voiding a test-in-
    progress. EPA has received feedback from the regulated industry that 
    the language in this section is confusing and that, furthermore, it is 
    inconsistent with customary laboratory practices. EPA agrees with this 
    criticism and has revised the cited section, substituting new exposure 
    time requirements.
        Specifically, EPA has incorporated into the regulations the 
    following minimum requirements: (1) A daily exposure must be at least 6 
    hours plus the time necessary to build the chamber atmosphere to 90 
    percent of the target exposure atmosphere; (2) A day in which the 
    minimum exposure time has not been achieved does not count as an 
    exposure day; (3) Exposures must be conducted at least 4 days per week; 
    (4) No more than two non-exposure days may occur consecutively during 
    the exposure period, including weekends and days on which the minimum 
    exposure time has not been met.
        These exposure rules purposely do not make allowance for Federal 
    holidays. EPA believes that additional ``down'' days for holidays could 
    impact the results of the 90-day test periods required under Tier 2, 
    and could interfere with EPA's ability to compare the results with 
    other F/FAs tested during cycles in which holidays did not occur. 
    Furthermore, if a particular health effects test guideline contains 
    exposure requirements that differ from these general rules, then the 
    specific requirements would take precedence. An example is the 
    Fertility and Teratology assessment at Sec. 79.63(c)(1), which requires 
    exposures to pregnant animal subjects each day during the first 15 days 
    of gestation.
        Under this change, biological tests which did not achieve exposures 
    consistent with the above rules would be considered void. The same 
    rules would be applied to both evaporative emission and exhaust 
    emission tests. See the revised language at Secs. 79.57(f)(3), 
    79.57(e)(2)(vii) and 79.61(d)(5). A new Sec. 79.63(e)(4)(iii) has been 
    added to emphasize the special exposure requirements of 
    Sec. 79.63(c)(1).
    
    VI. Units for Reporting Emissions Data
    
        Section 79.52(b)(1)(iv) specifies that manufacturers report 
    emissions data in units of grams per mile and weight percent total 
    hydrocarbons. These units are typically used to report emissions data 
    from light-duty vehicles operating on chassis dynamometers, but may be 
    inappropriate for reporting emissions data from other engine/vehicle 
    classes operating on engine dynamometers. As such, the wording of 
    paragraph 79.52(b)(1)(iv) has been changed to specify that F/FA 
    manufacturers should use brake-specific emission values in units of 
    grams per brake-horsepower/hour (gm/BHP-HR) where these units are 
    appropriate to the emissions test configuration and the vehicle/engine 
    being tested.
        If brake-specific emissions data are reported, then corresponding 
    changes are needed at several other points in the regulations. Section 
    79.52(b)(2)(iii)(D) specified that the concentration of individual 
    polyaromatic hydrocarbons (PAHs) and nitrated-polyaromatic hydrocarbons 
    (NPAHs) identified in Tier 1 emissions analyses shall be reported only 
    in units of microgram (g) per mile, with 0.001 g per 
    mile as the minimum threshold for identifying and reporting on a 
    particular PAH or NPAH compound. Similarly, Sec. 79.52(b)(2)(iii)(E) 
    specified that the concentration of each polychlorinated dibenzodioxin/
    polychlorinated dibenzofuran (PCDD/PCDF) identified in the Tier 1 
    emissions stream shall be reported in units of picograms (pg) per mile, 
    with 0.5 pg per mile or more as the minimum threshold for identifying 
    and reporting on a particular PCDD/PCDF compound.
        These sections have been revised to allow reporting of PAH, NPAH, 
    and PCDD/PCDF emissions data in units of grams per BHP-HR, where 
    appropriate. The counterpart to the g/mile reporting threshold for PAH 
    and NPAH compounds, expressed in terms of brake-specific emissions, 
    would be 0.5 nanograms per BHP-HR or more. Likewise, the counterpart to 
    the g/mile reporting threshold for PCDD/PCDF compounds would be 0.3 pg 
    per BHP-HR or more. These counterpart values were derived by applying 
    fleet average conversion factors for converting grams per mile to grams 
    per BHP-HR, specified in EPA Technical Report EPA-AA-SDSB-89-1.
        For similar reasons, Secs. 79.68 (f)(1) and (f)(5)(vi) of the 
    Salmonella typhimurium reverse mutation assay guidelines have been 
    modified to permit data from this assay to be presented in units of 
    either revertants per kilometer (mile) or
    
    [[Page 36509]]
    
    revertants per BHP-HR, whichever is appropriate to the case at hand.
    
    VII. Oxygenate Purity
    
        Section 79.51(i) specifies that a fuel manufacturer who reports the 
    potential use of more than one oxygenating additive in his non-baseline 
    fuel is responsible for testing (or participating in group testing) of 
    a separate fuel formulation for each such oxygenating additive. This 
    provision has caused some concern that the occurrence in an oxygenate 
    additive of unintended oxygenate byproducts of the manufacturing 
    process could multiply the testing responsibilities of a fuel 
    manufacturer. For example, concern has been expressed that the 
    occurrence of a small amount of tertiary-amyl-ethyl ether (TAEE) as an 
    unintended byproduct of ethyl-tertiary-butyl ether (ETBE) production 
    will affect the grouping of an ETBE additive and will cause a fuel 
    manufacturer who blends ETBE into his fuel to be responsible for 
    testing TAEE as well as ETBE (see docket item VI-D-10). This was not 
    EPA's intention in promulgating this provision. Section 79.51(i)(4) has 
    been revised to state that small amounts of unintended oxygenate 
    compounds occurring as byproducts of the manufacturing process of an 
    oxygenating additive do not affect the grouping of the affected F/FAs 
    nor the testing responsibilities of their manufacturers.
    
    E. Minor Syntax Changes and Clarifications
    
        Minor changes to the regulations are also needed to correct some 
    specific syntax errors. The phrase ``Within May 27, 1997,'' occurring 
    at the beginning of both Secs. 79.51(c)(1)(ii) (A) and (B), has been 
    changed to ``No later than May 27, 1997''. Similarly, the phrase 
    ``within May 26, 2000,'' occurring within Sec. 79.51(c)(1)(ii)(B), has 
    been changed to ``by May 26, 2000.'' The language at the beginning of 
    Sec. 79.51(e)(1), which read, ``A testing facility, emissions analysis 
    or health and/or welfare effects, shall permit * * * '' has been 
    changed to: ``A testing facility, whether engaged in emissions analysis 
    or health and/or welfare effects testing under these regulations, shall 
    permit * * * '' Some of the wording in Secs. 79.57(e) (2)(i), (2)(ii) 
    (2)(ii)(B), (3)(i), and (3)(i)(A) has been changed to clarify the 
    driving schedules to be used when operating the vehicle or engine to 
    generate combustion emissions for biological testing. The wording in 
    Secs. 79.51(h), (h)(1)(ii), and (h)(1)(ii) (A) and (B) dealing with 
    additives belonging to more than one fuel family, has been revised to 
    make this provision easier to understand, without changing the 
    substance of the requirements.
    
    VIII. Background Concentrations
    
        Section 79.52(b)(l)(iii) requires that the ambient/dilution air to 
    the engine generating emissions for characterization be analyzed for 
    levels of background chemical species present at the time of emission 
    sampling (for both combustion and evaporative emissions). These 
    background chemical species concentrations are to be reported with 
    emissions speciation data. This information is necessary so that it can 
    be subtracted from the measured combustion and evaporative 
    concentrations in order to determine the contribution for the F/FA. 
    Section 79.52(b)(l)(iii) is revised to clarify this and require that 
    only the corrected values be reported.
    
    IX. Repetitive Driving Schedules
    
        Section 79.57(e)(l)(I) requires the Light-Duty Urban Dynamometer 
    Driving Schedule (UDDS) or the Heavy Duty Engine Dynamometer Schedule 
    (EDS) as per 40 CFR part 86. Both of these driving schedules require 
    cold starts at the beginning of the cycle, and they include extended 
    engine-off times (10 minutes between bags 2 and 3 for light duty and 20 
    minutes between cold and hot cycles for heavy duty). While the 
    inclusion of cold starts and extended engine-off times are appropriate 
    for the certification of new vehicles and engines, these two 
    requirements pose significant impracticalities from the standpoint of 
    generating combustion emissions for animal exposures.
        First, if the UDDS were repeated as per the new vehicle 
    certification procedure, an eight hour animal exposure would require 24 
    engines sequenced for a cold start every 20 minutes. Second, the 
    engine-off time requirements from the certification procedure typically 
    involve extended periods of zero emissions. If these were incorporated 
    into the Tier 2 biological testing, the later requirements for a 
    ``settling chamber'' which will dampen out transients to the point that 
    exposure concentrations are held constant within 10%, would 
    result in the need for a huge settling chamber.
        Thus it is appropriate to allow the engine used for animal 
    exposures to be operated over repeated ``hot'' driving cycles. This 
    would entail repeated Bags 2 and 3 of the UDDS for light-duty vehicles 
    and back-to-back repeats of the heavy-duty transient cycle for heavy-
    duty engines. Both of these should be run without extended idles or 
    engine-off periods.
        Repeated operation of the engine over the hot portions (bags 2 and 
    3) of the FTP will avoid the extended engine-off periods which do not 
    contribute anything to animal exposure. This would minimize the 
    transients in the species concentrations, and reduce the need for a 
    large settling chamber, without changing the nature of the species 
    present for the animal exposure. A new Sec. 79.57(e)(1)(i)(C) has been 
    added to reflect this.
    
    X. Exposure Concentration
    
        Section 79.57(e)(2)(vi)(B) requires that the mean exposure 
    concentration in the inhalation chamber be within 10 percent of the 
    target concentration on 90 percent or more of the days. This implies 
    that target concentrations must be established for CO, CO2, 
    NOX, SOX, and total HC, and none can vary by more than 10% of 
    the targets on 90% or more of the exposure days. Given the fundamentals 
    of engine combustion and the transient nature of the driving cycles, it 
    is impossible to maintain all combustion emission products at a 
    constant level all of the time. The focus should be on the pollutants 
    which are limiting for the animals in terms of exposure, which is CO 
    for gasoline and NOX for diesel. The engine operator will only be 
    able to vary the exhaust dilution ratio, and thus control is assured 
    for only one pollutant (CO or NOX) at a time. Section 
    79.57(e)(2)(vi)(B) has been revised accordingly.
    
    XI. Dilution System
    
        Section 79.57(e)(2)(I) states that the biological tests are to be 
    performed ``* * * using emissions generated from the test vehicle or 
    engine operated in general accordance with the FTP procedures cited in 
    this section.'' Later in this section (at Sec. 79.57(e)(2)(iii)), the 
    regulations state that ``An apparatues to integrate the large 
    concentration swings typical of transient-cycle exhaust is to be used 
    between the FTP-Constant Volume Sampler (CVS) source of emissions and 
    the exposure chamber containing the animal test cages.'' These 
    statements imply that a CVS is required to be used as a first stage of 
    dilution in the delivery of combustion emissions for animal exposure. 
    However, we have received a comment that the dilution needed for 
    gasoline blends and for diesel fuels will be more than can be 
    accomplished with a CVS. Therefore, the test laboratory should not be 
    required to use a CVS as a first stage of dilution. In fact, it may be 
    most practical to use a constant dilution (rather than volume) sampler 
    to minimize transient concentrations for the animal exposures. Section
    
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    Sec. 79.57(e)(2)(iii) has been revised to allow the use of any dilution 
    system design that achieves the necessary concentration of CO or 
    NOX (whichever is limiting) and reduces transient concentration 
    exposure.
    
    XII. Collection of Particulates and Semi-volatiles
    
        Section 79.57(e)(1)(ii) states that emissions of particulates and 
    semi-volatiles are to be collected over triplicate FTP tests for light-
    duty vehicles and analyzed as part of the requirements for the 
    characterization of combustion emissions. However, the regulatory 
    language in Sec. 79.57(e)(1)(iii)(A) further states that ``If the mass 
    of particulate emissions or semi-volatile emissions obtained during one 
    driving cycle is not sufficient for characterization, then the driving 
    cycle may be performed again and the extracted fractions combined prior 
    to chemical analysis.'' The number of driving cycles that ``may be 
    performed'' is left unclear and potentially conflicts with the 
    triplicate FTP requirements. We have received a comment that the 
    available literature on gasoline blends suggests that the amount of 
    particulate and semi-volatile emissions collected from one FTP test on 
    a light-duty vehicle is extremely minute, if not less than the 
    detection limits afforded by measurement and analytical procedures 
    currently in use. Thus Sec. 79.57(e)(1)(iii)(A) has been revised to 
    clarify that no more than the three FTP tests are required to be 
    performed for the collection of particulate and semi-volatile 
    emissions. And, the test laboratory should focus on the 
    characterization of the limit detection for particulates and semi-
    volatile emissions.
    
    XIII. Environmental and Economic Impacts
    
        The environmental impacts of today's action are minimal, as 
    discussed above. Additionally, economic impacts are beneficial to 
    affected manufacturers due to the additional flexibility afforded in 
    today's notice. Minimal anti-competitive effects are expected. A 
    regulatory support document which presents EPA's analysis of the cost 
    impacts of the May 1994 rule is available in Public Docket A-90-07 
    located at Room M-1500, Waterside Mall (ground floor), U.S. 
    Environmental Protection Agency, 401 M St. S.W., Washington, D.C. 
    20460.
    
    XIV. Regulatory Flexibility Analysis
    
        EPA has determined that it is not necessary to prepare a regulatory 
    flexibility analysis in connection with this final rule. This rule will 
    reduce regulatory burdens on small businesses by reducing or 
    eliminating the reporting and testing requirements for many small 
    businesses. EPA has determined that this rule will not have a 
    significant adverse economic impact on a substantial number of small 
    businesses.
    
    XV. Administrative Designation
    
        Pursuant to Executive Order 12866 (58 FR 51735 [October 4, 1993]), 
    the Agency must determine whether a regulatory action is 
    ``significant'' and therefore subject to OMB review and the 
    requirements of the executive order. The order defines ``significant 
    regulatory actions 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 entitlement, 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.
        Pursuant to the terms of Executive Order 12866, it has been 
    determined that this direct final rule is not a ``significant 
    regulatory action''. The regulatory revisions in this notice will 
    reduce testing the requirements and costs.
    
    XVI. Paperwork Reduction Act
    
        The Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq., and 
    implementing regulations, 5 CFR Part 1320, do not apply to this action 
    as it does not involve the collection of information as defined 
    therein.
    
    XVII. Submission to Congress and the General Accounting Office
    
        Under section 801(a)(1)(A) of the Administrative Procedures Act 
    (APA) as amended by the Small Business Regulatory Enforcement Fairness 
    Act of 1996, EPA submitted 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. 
    The rule is not a ``major rule'' as defined by section 804(2) of the 
    APA as amended.
    
    XVIII. Unfunded Mandates Act
    
        Under section 202 of the Unfunded Mandates Reform Act of 1995 
    (``Unfunded Mandates Act''), signed into law on March 22, 1995, EPA 
    must prepare a budgetary impact statement to accompany any proposed or 
    final rule that includes a Federal mandate that may result in 
    expenditure by State, local, and tribal governments, in the aggregate; 
    or by the private sector, of $100 million or more. Under Section 205, 
    EPA must select the most cost-effective and least burdensome 
    alternative that achieves the objectives of the rule and is consistent 
    with statutory requirements. Section 203 requires EPA to establish a 
    plan for informing and advising any small governments that may be 
    significantly or uniquely impacted by the rule.
        The Agency has determined that the action promulgated today does 
    not include a federal mandate that may result in estimated costs of 
    $100 million or more to either State, local, or tribal governments in 
    the aggregate, or to the private sector. This proposed action does not 
    establish regulatory requirements that may significantly or uniquely 
    affect small governments. In fact, this proposed action has the net 
    effect of reducing the burden of the fuel and fuel additive 
    registration program on regulated entities. Therefore, the requirements 
    of the Unfunded Mandates Act do not apply to this action.
    
    XIX. Statutory Authority
    
        The statutory authority for this direct final rule is provided by 
    sections 205 (b) and (c), 211, and 301(a) of the Clean Air Act as 
    amended (42 U.S.C. 7524 (b) and (c), 7545, and 7601(a), Public Law 95-
    95).
    
    List of Subjects in 40 CFR Part 79
    
        Environmental protection, Fuel, Fuel additive, Gasoline, Motor 
    vehicle pollution, Penalties.
    
        Dated: June 27, 1996.
    Carol M. Browner,
    Administrator.
    
        For the reasons set forth in the preamble, part 79 of title 40 of 
    the Code of Federal Regulations is amended as follows:
    
    PART 79--[AMENDED]
    
        1. The authority citation for part 79 continues to read as follows:
    
        Authority: 42 U.S.C. 7414, 7524, 7545 and 7601.
    
        2. Section 79.51 is amended by revising paragraphs (c)(1)(ii)(A), 
    (c)(1)(ii)(B), the first sentence of paragraphs (e)(1), (h) 
    introductory text,
    
    [[Page 36511]]
    
    (h)(1)(ii); and by adding a new paragraph (i)(4) to read as follows:
    
    
    Sec. 79.51  General requirements and provisions.
    
     * * * * *
        (c) * * *
        (1) * * *
        (ii) * * *
        (A) No later than May 27, 1997, all applicable Tier 1 and Tier 2 
    requirements must be submitted to EPA, pursuant to Secs. 79.52, 79.53, 
    and 79.59; or
        (B) No later than May 27, 1997, all applicable Tier 1 requirements 
    (pursuant to Secs. 79.52 and 79.59), plus evidence of a contract with a 
    qualified laboratory (or other suitable arrangement) for completion of 
    all applicable Tier 2 requirements, must be submitted to EPA. For this 
    purpose, a qualified laboratory is one which can demonstrate the 
    capabilities and credentials specified in Sec. 79.53(c)(1). In 
    addition, by May 26, 2000, all applicable Tier 2 requirements (pursuant 
    to Secs. 79.53 and 79.59) must be submitted to EPA.
     * * * * *
        (e) Inspection of a testing facility. (1) A testing facility, 
    whether engaged in emissions analysis or health and/or welfare effects 
    testing under the regulations in this subpart, shall permit an 
    authorized employee or duly designated representative of EPA, at 
    reasonable times and in a reasonable manner, to inspect the facility 
    and to inspect (and in the case of records also to copy) all records 
    and specimens required to be maintained regarding studies to which this 
    subpart applies. * * *
     * * * * *
        (h) Special Requirements for Additives. When an additive is the 
    test subject, the following rules apply:
     * * * * *
        (1) * * *
        (ii) Additives belonging to more than one fuel family.
        (A) If an additive product is registered in two or more fuel 
    families as of May 27, 1994, then the manufacturer of that additive is 
    responsible for testing (or participating in group testing of) the 
    respective additive/base fuel mixtures in compliance with the 
    requirements of this subpart for each fuel family in which the 
    manufacturer wishes to maintain a registration for its additive.
        (B) If a manufacturer is seeking to register such additive in two 
    or more fuel families then, for testing and registration purposes, the 
    additive shall be considered to be a member of each fuel family in 
    which the manufacturer is seeking registration. The manufacturer is 
    responsible for testing (or participating in group testing of) the 
    respective additive/base fuel mixture in compliance with the 
    requirements of this subpart for each fuel family in which the 
    manufacturer wishes to obtain a product registration for its additive.
    * * * * *
        (i) * * *
        (4) The presence in a particular oxygenating additive of small 
    amounts of other unintended oxygenate compounds as byproducts of the 
    manufacturing process of the given oxygenating additive does not affect 
    the grouping of that additive and does not create multiple testing 
    responsibilities for manufacturers who blend that additive into fuel.
     * * * * *
        3. Section 79.52 is amended by revising paragraphs (b)(1)(iii) and 
    (b)(1)(iv), (b)(2)(iii)(D) introductory text, and (b)(2)(iii)(E) 
    introductory text, to read as follows:
    
    
    Sec. 79.52  Tier 1.
    
    * * * * *
        (b) * * *
        (1) * * *
        (iii) Measurement of background emissions: It is required that 
    ambient/dilution air be analyzed for levels of background chemical 
    species present at the time of emissions sampling (for both combustion 
    and evaporative emissions) and that sample values be corrected by 
    substracting the concentrations contributed by the ambient/dilution 
    air. Background chemical species measurement/analysis during the FTP is 
    specified in Secs. 86.109-94(c)(5) and 86.135-94 of this chapter.
        (iv) Concentrations of emission products shall be reported either 
    in units of grams per mile (g/mi) or grams per brake-horsepower/hour 
    (g/bhp-hr) (for chassis dynamometer and engine dynamometer test 
    configurations, respectively), as well as in units of weight percent of 
    measured total hydrocarbons.
     * * * * *
        (2) * * *
        (iii) * * *
        (D) The analytical method used to measure species of PAHs and NPAHs 
    should be capable of detecting at least 1 ppm (equivalent to 0.001 
    microgram (g) of compound per milligram of organic extract) of 
    these compounds in the extractable organic matter. The concentration of 
    each individual PAH or NPAH compound identified shall be reported in 
    units of microgram per mile or nanograms per brake-horsepower/hour (for 
    chassis dynamometer and engine dynamometer test configurations, 
    respectively). Each compound which is present at 0.001 g per 
    mile (0.5 nanograms per brake-horsepower/hour) or more must be 
    identified, measured, and reported. The following individual species 
    shall be measured:
     * * * * *
        (E) The analytical method used to measure species and classes of 
    PCDD/PCDFs should be capable of detecting at least 1 part per trillion 
    (ppt) (equivalent to 0.001 picogram (pg) of compound per milligram of 
    organic extract) of these compounds in the extractable organic matter. 
    The concentration of each individual PCDD/PCDF compound identified 
    shall be reported in units of picograms (pg) per mile or picograms per 
    brake-horsepower/hour (for chassis dynamometer and engine dynamometer 
    test configurations, respectively). Each compound which is present at 
    0.5 pg/mile (0.3 pg/bhp-hr) or more must be identified, measured, and 
    reported.
    * * * * *
        4. Section 79.57 is amended by adding paragraphs (b)(2)(i), 
    (b)(2)(ii), (b)(2)(iii) and (e)(1)(i)(C); and by revising paragraphs 
    (e)(1)(iii)(A), (e)(2)(i), (e)(2)(ii) introductory text, (e)(2)(ii)(B), 
    (e)(2)(iii) introductory text, (e)(2)(iii)(C), (e)(2)(vi)(B), 
    (e)(2)(vii), (e)(3)(i)(A), and (f)(3); and by revising the word 
    ``cycle'' to read ``schedule'' in paragraph (e)(3)(i) introductory 
    text; to read as follows:
    
    
    Sec. 79.57  Emission generation.
    
    * * * * *
        (b) * * *
        (2) * * *
        (i) A vehicle or engine may be used to generate emissions for the 
    testing of more than one fuel or additive, provided that all such fuels 
    and additives belong to the same fuel family pursuant to 
    Sec. 79.56(e)(i), and that, once a vehicle or engine has been used to 
    generate emissions for an atypical fuel or additive (pursuant to 
    Sec. 79.56(e)(2)(iii)), it shall not be used in the testing of any 
    other fuel or additive. Paragraphs (a) (2) and (3) of this section 
    shall apply only to the first fuel or additive tested.
        (ii) Prior to being used to generate emissions for testing an 
    additional fuel or additive, a vehicle or engine which has previously 
    been used for testing a different fuel or additive shall undergo an 
    effective intermediate preconditioning cycle to remove the previously 
    used fuel and its emissions from the vehicle's fuel and exhaust systems 
    and from the combustion emission and evaporative emission control 
    systems, if any.
    
    [[Page 36512]]
    
        (iii) Such preconditioning shall include, at a minimum, the 
    following steps:
        (A) The canister (if any) shall be removed from the vehicle and 
    purged with 300  deg.F nitrogen at 20 liters per minute until the 
    incremental weight loss of the canister is less than 1 gram in 30 
    minutes. This typically takes 3-4 hours and removes 100 to 120 grams of 
    adsorbed gasoline vapors.
        (B) The fuel tank shall be drained and filled to capacity with the 
    new test fuel or additive/fuel mixture.
        (C) The vehicle or engine shall be operated until at least 95% of 
    the fuel tank capacity is consumed.
        (D) The purged canister shall be returned to the vehicle.
        (E) The fuel tank shall be drained and filled to 40% capacity with 
    test fuel.
        (F) Two-hour fuel tank heat builds from 72-120  deg.F shall be 
    performed repeatedly as necessary to achieve canister breakthrough. The 
    fuel tank must be drained and filled prior to each heat build.
     * * * * *
        (e) * * *
        (1) * * *
        (i) * * *
        (C) For Tier 2 testing, the engines shall operate on repeated bags 
    2 and 3 of the UDDS or back to back repeats of the heavy-duty transient 
    cycle of the EDS.
    * * * * *
        (iii) * * *
        (A) In the case of combustion emissions generated from light-duty 
    vehicles/engines, the samples consist of three bags of vapor emissions 
    (one from each segment of the light-duty exhaust emission cycle) plus 
    one sample of particulate-phase emissions and one sample of semi-
    volatile-phase emissions (collected over all segments of the exhaust 
    emission cycle). If the mass of particulate emissions or semi-volatile 
    emissions obtained during one driving cycle is not sufficient for 
    characterization, up to three driving cycles may be performed and the 
    extracted fractions combined prior to chemical analysis. Particulate-
    phase emissions shall not be combined with semi-volatile-phase 
    emissions. The test laboratory should focus on the characterization of 
    the limit of detection for particulates and semi-volatile emissions.
    * * * * *
        (2) * * * Generating whole combustion emissions for biological 
    testing. (i) Biological tests requiring whole combustion emissions 
    shall be conducted using emissions generated from the test vehicle or 
    engine operated in accordance with general FTP requirements.
        (ii) Light-duty test vehicles/engines shall be repeatedly operated 
    over the Urban Dynamometer Driving Schedule (UDDS) (or equivalent 
    engine dynamometer trace, per paragraph (e)(1)(i)(A) of this section) 
    and heavy-duty test engines shall be repeatedly operated over the 
    Engine Dynamometer Schedule (EDS) (see 40 CFR part 86, appendix I).
    * * * * *
        (B) The UDDS or EDS shall be repeated as many times as required for 
    the biological test session.
    * * * * *
        (iii) An apparatus to integrate the large concentration swings 
    typical of transient-cycle exhaust is to be used between the source of 
    emissions and the exposure chamber containing the animal test cages(s). 
    The purpose of such apparatus is to decrease the variability of the 
    biological exposure atmosphere and achieve the necessary concentration 
    of CO or NOX, whichever is limiting.
    * * * * *
        (C) The mixing chamber (or any alternative emission moderation 
    apparatus) must function such that the average concentration of total 
    hydrocarbons leaving the apparatus shall be within 10 percent of the 
    average concentration of hydrocarbons entering the chamber, taking into 
    account any further intentional dilution occurring in the apparatus 
    pursuant to paragraph (e)(2)(iv)(C) of this section.
    * * * * *
        (vi) * * *
        (B) These procedures include requirements that the mean exposure 
    concentration in the inhalation test chamber shall be within 10 percent 
    of the target concentration for the single species being controlled 
    (establish in the development phase of testing) on 90 percent or more 
    of exposure days and that daily monitoring of CO, CO2, NOX, 
    SOX, and total hydrocarbons in the exposure chamber shall be 
    required. Analysis of the particle size distribution shall also be 
    performed to established the stability and consistency of particle size 
    distribution in the test exposure.
    * * * * *
        (vii) To allow for customary laboratory scheduling and unforeseen 
    problems affecting the combustion emission generation or dilution 
    equipment, biological exposures may be interrupted on limited 
    occasions, as specified in Sec. 79.61(d)(5). Interruptions exceeding 
    these limitations shall cause the affected test(s) to be void. Testers 
    shall be aware of concerns for backup vehicles/engines cited in 
    paragraph (a)(7)(ii) of this section.
    * * * * *
        (3) * * *
        (i) * * *
    * * * * *
        (A) Particulate emissions shall be collected on particulate filters 
    and extracted from the collection equipment for use in biological 
    tests. The number of repetitions of the applicable driving schedule 
    required to collect sufficient quantities of the particulate emissions 
    will vary, depending on the characteristics of the engine, the test 
    fuel, and the requirements of the biological test protocol. The 
    particulate sample may be collected on one or more filters, as 
    necessary.
    * * * * *
        (f) * * *
        (3) For biological testing, vapor shall be withdrawn from the EEG 
    at a constant rate, diluted with air as required for the particular 
    study, and conducted immediately to the biological testing chamber(s) 
    in a manner similar to the method used in Sec. 79.57(e), excluding the 
    mixing chamber therein. The rate of emission generation shall be high 
    enough to supply the biological exposure chamber with sufficient 
    emissions to allow for a minimum of fifteen air changes per exposure 
    chamber per hour. To allow for customary laboratory scheduling and for 
    unforeseen problems with the evaporative emission generation or 
    dilution equipment, biological exposures may be interrupted on limited 
    occasions, as specified in Sec. 79.61(d)(5). Interruptions exceeding 
    these limitations shall cause the affected test(s) to be void.
    * * * * *
        5. Section 79.61 is amended by revising paragraph (d)(5) to read as 
    follows:
    
    
    Sec. 79.61  Vehicle emissions inhalation exposure guideline.
    
    * * * * *
        (d) * * *
    * * * * *
        (5) Exposure Conditions. The preferred exposure regimen consists of 
    exposing the study animals to the test atmosphere on a repeated basis 
    for at least 6 hours per day on a 7-day per week basis for the exposure 
    period. However, unless precluded by the requirements of a particular 
    test protocol, exposures based on a nominal 5-day-per-week regimen will 
    be considered acceptable, subject to the following rules:
        (i) Each daily exposure during the exposure period must be at least 
    6 hours
    
    [[Page 36513]]
    
    plus the time necessary to build the chamber atmosphere to 90 percent 
    of the target exposure atmosphere. A day in which this minimum exposure 
    time has not been achieved does not count as an exposure day.
        (ii) Nominally, animal exposures should be conducted for six hours 
    per day for five days per week. In no case should the exposures occur 
    less than four days per week for a total of 652 exposure 
    days.
        (iii) No more than two non-exposure days may occur consecutively 
    during the exposure period, including days on which the minimum 
    exposure time has not been met.
    * * * * *
        6. Section 79.63 is amended by adding a new paragraph (e)(4)(iii) 
    to read as follows:
    
    
    Sec. 79.63  Fertility assessment/teratology.
    
    * * * * *
        (e) * * *
        (4) * * *
        (iii) Pregnant females shall be exposed to the test atmosphere on 
    each and every day between (and including) the first and fifteenth day 
    of gestation.
    * * * * *
        7. Section 79.68 is amended by revising paragraphs (f)(1) and 
    (f)(5)(vi) to read as follows:
    
    
    Sec. 79.68  Salmonella typhimurium reverse mutation assay.
    
    * * * * *
        (f) Data and report--(1) Treatment of results. Data shall be 
    presented as number of revertant colonies per plate, revertants per 
    kilogram (or liter) of fuel, and as revertants per kilometer (or mile, 
    or brake-horsepower/hour, as appropriate) for each replicate and dose. 
    These same measures shall be recorded on both the negative and positive 
    control plates. The mean number of revertant colonies per plate, 
    revertants per kilogram (or liter) of fuel, and revertants per 
    kilometer (or mile, or brake-horsepower/hour), as well as individual 
    plate counts and standard deviations shall be presented for the test 
    substance, positive control, and negative control plates.
    * * * * *
        (5) * * *
        (vi) Individual plate counts, mean number of revertant colonies per 
    plate, number of revertants per kilometer (or mile, or brake-
    horsepower/hour), and standard deviation; and
    * * * * *
    [FR Doc. 96-17549 Filed 7-10-96; 8:45 am]
    BILLING CODE 6560-50-P
    
    
    

Document Information

Effective Date:
8/26/1996
Published:
07/11/1996
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Direct final rule.
Document Number:
96-17549
Dates:
This action will be effective on August 26, 1996 unless EPA receives an adverse comment or a request for a public hearing by August 12, 1996. If EPA receives an adverse comment or hearing request by that date, EPA will withdraw this action via a document in the Federal
Pages:
36506-36513 (8 pages)
Docket Numbers:
FRL-5532-4
PDF File:
96-17549.pdf
CFR: (13)
40 CFR 79.63(c)(1)
40 CFR 79.51(e)(1)
40 CFR 79.56(e)(1))
40 CFR 79.56(e)(i)
40 CFR 79.56(e)(2)(iii))
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