98-34702. Copper-ethylenediamine Complex; Exemption From the Requirement of a Tolerance  

  • [Federal Register Volume 64, Number 1 (Monday, January 4, 1999)]
    [Rules and Regulations]
    [Pages 41-44]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-34702]
    
    
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    ENVIRONMENTAL PROTECTION AGENCY
    
    40 CFR Part 180
    
    [OPP-300777; FRL-6052-5]
    RIN 2070-AB78
    
    
    Copper-ethylenediamine Complex; Exemption From the Requirement of 
    a Tolerance
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Final rule.
    
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    SUMMARY: This rule establishes an exemption from the requirement of a 
    tolerance for residues of copper-ethylenediamine complex in or on 
    potatoes when applied/used in accordance with good agricultural 
    practice as an active ingredient in pesticide formulations as a 
    desiccant/harvest aid. The Interregional Research Project Number 4 (IR-
    4) submitted a petition to EPA under the Federal Food, Drug and 
    Cosmetic Act as amended by the Food Quality Protection Act of 1996 
    (Pub. L. 104-170) requesting an exemption from the requirement of a 
    tolerance. This regulation eliminates the need to establish a maximum 
    permissible level for residues of Copper-ethylenediamine complex in or 
    on potatoes.
    
    DATES: This regulation is effective February 3, 1999. Objections and 
    requests for hearings must be received by EPA on or before March 5, 
    1999.
    
    ADDRESSES: Written objections and hearing requests, identified by the 
    docket control number [OPP-300777], must be submitted to: Hearing Clerk 
    (1900), Environmental Protection Agency, Rm. M3708, 401 M St., SW., 
    Washington, DC 20460. Fees accompanying objections and hearing requests 
    shall be labeled ``Tolerance Petition Fees'' and forwarded to: EPA 
    Headquarters Accounting Operations Branch, OPP (Tolerance Fees), P.O. 
    Box 360277M, Pittsburgh, PA 15251. A copy of any objections and hearing 
    requests filed with the Hearing Clerk identified by the docket control 
    number, [OPP-300777], must also be submitted to: Public Information and 
    Records Integrity Branch, Information Resources and Services Division 
    (7502C), Office of Pesticide Programs, Environmental Protection Agency, 
    401 M St., SW., Washington, DC 20460. In person, bring a copy of 
    objections and hearing requests to Rm. 119, Crystal Mall 2 (CM #2), 
    1921 Jefferson Davis Hwy., Arlington, VA.
        A copy of objections and hearing requests filed with the Hearing 
    Clerk may be submitted electronically by sending electronic mail (e-
    mail) to: opp-docket@epamail.epa.gov. Copies of electronic objections 
    and hearing requests must be submitted as an ASCII file avoiding the 
    use of special characters and any form of encryption. Copies of 
    electronic objections and hearing requests will also be accepted on 
    disks in WordPerfect 5.1/6.1 file format or ASCII file format. All 
    copies of electronic objections and hearing requests must be identified 
    by the docket number [OPP-300777]. No Confidential Business Information 
    (CBI) should be submitted through e-mail. Copies of electronic 
    objections and hearing requests on this rule may be filed online at 
    many Federal Depository Libraries.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Sidney Jackson (PM5), 
    Registration Division 7505C, Office of Pesticide Programs, 
    Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
    Office location, telephone number, and e-mail address: CM #2, 1921 
    Jefferson Davis Hwy., Arlington, VA, (703) 305-7610, e-mail: 
    jackson.sidney@epamail.epa.gov.
    
    SUPPLEMENTARY INFORMATION: In the Federal Register of October 29, 1997 
    (62 FR 56179) (FRL-5749-7), EPA issued a notice pursuant to section 408 
    of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a as 
    amended by the Food Quality Protection Act of 1996 announcing the 
    filing of a pesticide tolerance petition by IR-4. This notice included 
    a summary of the petition prepared by the Griffin Corporation. There 
    were no comments received in response to the notice of filing.
        The petition requested that 40 CFR part 180 be amended by 
    establishing an exemption from the requirement of a tolerance for 
    residues of Copper-ethylenediamine complex.
    
    I. Background and Statutory Authority
    
        New section 408(b)(2)(A)(i) of the FFDCA allows EPA to establish an 
    exemption from the requirement for a tolerance (the legal limit for a 
    pesticide chemical residue in or on a food) only if EPA determines that 
    the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to 
    mean that ``there is a reasonable certainty that no harm will result 
    from aggregate exposure to the pesticide chemical residue, including 
    all anticipated dietary exposures and all other exposures for which 
    there is reliable information.'' This includes exposure through 
    drinking water and in residential settings, but does not include 
    occupational exposure. Section 408(b)(2)(C) requires EPA to give 
    special
    
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    consideration to exposure of infants and children to the pesticide 
    chemical residue in establishing a tolerance and to ``ensure that there 
    is a reasonable certainty that no harm will result to infants and 
    children from aggregate exposure to the pesticide chemical residue...''
        EPA performs a number of analyses to determine the risks from 
    aggregate exposure to pesticide residues. First, EPA determines the 
    toxicity of pesticides. Second, EPA examines exposure to the pesticide 
    through food, drinking water, and through other exposures that occur as 
    a result of pesticide us in residential settings.
    
    II. Toxicological Profile
    
        Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the 
    available scientific data and other relevant information in support of 
    this action and considered its validity, completeness and reliability 
    and the relationship of this information to human risk. EPA has also 
    considered available information concerning the variability of the 
    sensitivities of major identifiable subgroups of consumers, including 
    infants and children. The nature of the toxic effects caused by Copper-
    ethylenediamine complex are discussed below:
        Copper-ethylenediamine complex and copper sulfate pentahydrate are 
    the active ingredient components of INFERNO Plant 
    Desiccant, a formulation containing 8% elemental copper. An identical 
    product, KOMEEN Aquatic Herbicide (EPA Reg. No. 1812-312), is 
    approved for use in slow moving or quiescent bodies of water including 
    potable water reservoirs. Copper sulfate pentahydrate is already exempt 
    from the requirement of a tolerance according to 40 CFR 180.1001(b)(1).
        Copper is ubiquitous in nature and is a nutritionally required 
    element for plants and animals. The National Academy of Science has 
    established a recommended daily dietary intake for copper. In addition, 
    humans possess a natural efficient homeostatic mechanism for regulating 
    copper body levels over a wide range of dietary intake. The toxicity of 
    the copper ion is well-characterized in the published literature. There 
    is no evidence of any chronic effects induced by dietary ingestion of 
    copper unless the intake is of such enormous magnitude that there is a 
    disruption of the natural homeostatic mechanism for controlling body 
    levels. Consequently, there is no reason to expect that long-term 
    exposure to the copper ion in the diet is likely to lead to adverse 
    health effects.
        The EPA toxicology database on copper-ethylenediamine complex shows 
    this compound has similar toxicological properties to other copper 
    compounds already exempt from the requirement of a tolerance such as 
    copper hydroxide and cuprous oxide.
        The Agency does not require subchronic, chronic, reproductive or 
    developmental toxicity studies for the copper salts.
        Results of a battery of acute toxicity studies show copper-
    ethylenediamine complex (Komeen) is slightly to moderately toxic upon 
    acute oral, dermal and inhalation exposure, slightly irritating to the 
    skin and moderately irritating to the eye.
        In rats, the acute oral lethal dose (LD) 50 (95% 
    confidence limits) for Komeen was 498 milligram (mg)/kilogram (kg) 
    (349-710 mg/kg) for a Toxicity Category II classification.
        The acute dermal LD50 in rabbits for Komeen was 
    determined to be > 2,000 mg/kg (Toxicity Category III).
        In acute inhalation studies with Sprague-Dawley rats, the lethal 
    concentration (LC) 50 (95% confidence limits) for Komeen was 
    0.81 mg/liter(l) (0.26-1.37 mg/l).
        In rabbit studies, Komeen was shown to be moderately irritating to 
    the eye with all signs of ocular irritation cleared within 10 days of 
    treatment (Toxicity Category III).
    
    III. Aggregate Exposures
    
        In examining aggregate exposure, FFDCA section 408 directs EPA to 
    consider available information concerning exposures from the pesticide 
    residue in food and all other non-occupational exposures, including 
    drinking water from groundwater or surface water and exposure through 
    pesticide use in gardens, lawns, or buildings (residential and other 
    indoor uses).
    
    A. Dietary Exposure
    
        1. Food. Based on the proposed used pattern of potato vine 
    desiccation, minimal copper residues are expected to occur in potatoes 
    and the dietary exposure would be negligible by comparison to the 
    normal daily intake of copper. A single day's diet may contain 10 mg or 
    more of copper. The daily recommended allowance of copper for adults 
    nutritional needs is 2 mg.
        Copper levels toxic to plants induce a chlorosis condition which 
    causes decreased growth and yield before hazardous copper levels are 
    reached. Since the INFERNO formulation will be 
    applied to the potato vine above ground, the potato tubers below ground 
    will not be directly treated. Moreover, copper is naturally found in 
    several types of food, such as fruits and vegetables, at levels ranging 
    from 0.3 to 3.9 ppm. The Agency believes that residues of copper, if 
    any, in potatoes from pesticidal application of copper-ethylenediamine 
    complex are not likely to exceed these naturally occurring levels. 
    Additionally, the Agency has waived all residue chemistry study 
    requirements for copper-ethylenediamine complex since copper is 
    naturally occurring in plants and it is impossible to distinguish 
    copper residues resulting from naturally occurring copper or copper-
    ethylenediamine complex.
        2. Drinking water exposure. Copper is ubiquitous in the environment 
    and found in natural water. Komeen is registered for use in water 
    including potable water, livestock watering, fish hatcheries, etc. The 
    average copper concentration in drinking water is 0.13 ppm. In 1991, 
    the US EPA established a maximum contamination level (MCL) for copper 
    in drinking water of 1.3 mg/l. The Agency believes that no impact on 
    copper levels found naturally in water would occur as a result of 
    potato vine desiccant use of copper-ethylenediamine complex.
    
    B. Other Non-Occupational Exposure
    
        Copper is registered for use as an aquatic herbicide for outdoor 
    residential sites. Any contributions to aggregate exposure from this 
    use would not be expected to be significant.
        1. Dermal exposure. No significant dermal exposure would be 
    expected to result from intended use of copper-ethylenediamine complex.
        2. Inhalation exposure. Air concentrations of copper are relatively 
    low. A study based on several thousand samples assembled by EPA's 
    Environmental Monitoring Systems Laboratory showed copper levels 
    ranging from 0.003 to 7.32 micrograms per cubic meter. Other studies 
    indicate that air levels of copper are much lower. The Agency does not 
    expect the air concentration of copper to be significantly effected by 
    the use of copper-ethylenediamine complex on potatoes.
    
    IV. Cumulative Effects
    
        The Agency believes that copper has no significant toxicity to 
    humans and that no cumulative adverse effects are expected from long-
    term exposure to copper salts. No other elements are expected to 
    produce cumulative toxicity with copper-ethylenediamine complex.
    
    [[Page 43]]
    
    V. Determination of Safety for U.S. Population, Infants and 
    Children
    
        Copper compounds such as copper sulfate pentahydrate are considered 
    as Generally Recognized as Safe (GRAS) by the Food and Drug 
    Administration. EPA has exempted various copper compounds from the 
    requirement of a tolerance when used as aquatic herbicides (40 CFR 
    180.1021). Copper compounds are also exempt from the requirement of a 
    tolerance when applied to growing crops when used as a plant fungicide 
    in accordance with good agricultural practices (40 CFR 180.1001(b)(1)).
        1. U.S. population. Copper is a component of the human diet and an 
    essential element. Use of copper-ethylenediamine complex is not 
    expected to increase the amount of copper in the diet as a result of 
    potato vine desiccation.
        2. Infants and children. Infants and children also require copper 
    in their diets and EPA believes that no special sensitivity for this 
    population subgroup would be expected as a result of the proposed use. 
    Because of copper's low toxicity, EPA has not used a safety factor 
    approach to analyzing the safety of copper-ethylenediamine complex used 
    a potato vine desiccant. For similar reasons, an additional tenfold 
    margin of safety is not necessary for the protection of infants and 
    children.
        Based on the information in this preamble, EPA concludes that there 
    is a reasonable certainty of no harm to the general population, 
    including infants and children, from aggregate exposure to Copper-
    ethylenediamine complex residues. Accordingly, EPA finds that exempting 
    Copper-ethylenediamine complex from the requirement of a tolerance will 
    be safe.
    
    VI. Other Considerations
    
    A. Endocrine Disruptors
    
         Since copper is required for homeostasis, low copper dietary 
    exposures would not be expected to result in any adverse endocrine 
    effects. Moreover, the Agency has no information to suggest that copper 
    will adversely affect the immune or endocrine systems. The Agency is 
    not requiring information on the endocrine effects of copper at this 
    time; Congress has allowed three (3) years after August 3, 1996, for 
    the Agency to implement a screening program with respect to endocrine 
    effects.
    
    B. Analytical Method(s)
    
         A practical analytical method for copper-ethylenediamine complex 
    is not required for crop use since it is expected that no residues will 
    occur in potatoes. Additionally, the Agency is establishing an 
    exemption from the requirement of a tolerance without any numeric 
    limitation; therefore, the Agency is not requiring an analytical method 
    for enforcement purposes for copper-ethlenediamine complex.
    
    C. Existing Tolerances
    
        There are no existing tolerance(s) for copper-ethylenediamine 
    complex.
    
    D. International Tolerances
    
        No maximum residue level has been established for copper-
    ethylenediamine complex by the Codex Alimentarius Commission.
    
    VII. Objections and Hearing Requests
    
        The new FFDCA section 408(g) provides essentially the same process 
    for persons to ``object'' to a regulation for an exemption from the 
    requirement of a tolerance issued by EPA under new section 408(d)and as 
    was provided in the old section 408 and in section 409. However, the 
    period for filing objections is 60 days, rather than 30 days. EPA 
    currently has procedural regulations which governs the submission of 
    objections and hearing requests. These regulations will require some 
    modification to reflect the new law. However, until those modifications 
    can be made, EPA will continue to use those procedural regulations with 
    appropriate adjustments to reflect the new law.
        Any person may, by Marach 5, 1999, file written objections to any 
    aspect of this regulation and may also request a hearing on those 
    objections. Objections and hearing requests must be filed with the 
    Hearing Clerk, at the address given under the ``ADDRESSES'' section (40 
    CFR 178.20). A copy of the objections and/or hearing requests filed 
    with the hearing clerk should be submitted to the OPP docket for this 
    rulemaking. The objections submitted must specify the provisions of the 
    regulation deemed objectionable and the grounds for the objections (40 
    CFR 178.25). Each objection must be accompanied by the fee prescribed 
    by 40 CFR 180.33(i). EPA is authorized to waive any fee requirement 
    ``when in the judgement of the Administrator such a waiver or refund is 
    equitable and not contrary to the purpose of this subsection.'' For 
    additional information regarding tolerance objection fee waivers, 
    contact James Tompkins, Registration Division (7505C), Office of 
    Pesticide Programs, Environmental Protection Agency, 401 M St., SW., 
    Washington, DC 20460. Office location, telephone number, and e-mail 
    address: Rm. 239, CM #2, 1921 Jefferson Davis Hwy., Arlington, VA, 
    (703) 305-5697, tompkins.jim@epa.gov. Requests for waiver of tolerance 
    objection fees should be sent to James Hollins, Information Resources 
    and Services Division (7502C), Office of Pesticide Programs, 
    Environmental Protection Agency, 401 M St., SW., Washington, DC 20460.
        If a hearing is requested, the objections must include a statement 
    of the factual issues(s) on which a hearing is requested, the 
    requestor's contentions on such issues, and a summary of any evidence 
    relied upon by the objector (40 CFR 178.27). A request for a hearing 
    will be granted if the Administrator determines that the material 
    submitted shows the following: There is a genuine and substantial issue 
    of fact; there is a reasonable possibility that available evidence 
    identified by the requestor would, if established resolve one or more 
    of such issues in favor of the requestor, taking into account 
    uncontested claims or facts to the contrary; and resolution of the 
    factual issues(s) in the manner sought by the requestor would be 
    adequate to justify the action requested (40 CFR 178.32). Information 
    submitted in connection with an objection or hearing request may be 
    claimed confidential by marking any part or all of that information as 
    CBI. Information so marked will not be disclosed except in accordance 
    with procedures set forth in 40 CFR part 2. A copy of the information 
    that does not contain CBI must be submitted for inclusion in the public 
    record. Information not marked confidential may be disclosed publicly 
    by EPA without prior notice.
    
    VIII. Public Record and Electronic Submissions
    
        EPA has established a record for this rulemaking under docket 
    control number [OPP-300777] (including any comments and data submitted 
    electronically). A public version of this record, including printed, 
    paper versions of electronic comments, which does not include any 
    information claimed as CBI, is available for inspection from 8:30 a.m. 
    to 4 p.m., Monday through Friday, excluding legal holidays. The public 
    record is located in Room 119 of the Public Information and Records 
    Integrity Branch, Information Resources and Services Division (7502C), 
    Office of Pesticide Programs, Environmental Protection Agency, CM #2, 
    1921 Jefferson Davis Hwy., Arlington, VA.
        Objections and hearing requests may be sent by e-mail directly to 
    EPA at:
        opp-docket@epa.gov.
    
    
    
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        E-mailed objections and hearing requests must be submitted as an 
    ASCII file avoiding the use of special characters and any form of 
    encryption.
        The official record for this regulation, as well as the public 
    version, as described in this unit will be kept in paper form. 
    Accordingly, EPA will transfer any copies of objections and hearing 
    requests received electronically into printed, paper form as they are 
    received and will place the paper copies in the official record which 
    will also include all comments submitted diredtlly in writing. The 
    official record is the paper record maintained at the Virginia address 
    in ``ADDRESSES'' at the beginning of this document.
    
    IX. Regulatory Assessment Requirements
    
    A. Certain Acts and Executive Orders
    
        This final rule establishes an exemption from the tolerance 
    requirement under section 408(d) of the FFDCA in response to a petition 
    submitted to the Agency. The Office of Management and Budget (OMB) has 
    exempted these types of actions from review under Executive Order 
    12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 
    1993). This final rule does not contain any information collections 
    subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
    U.S.C. 3501 et seq., or impose any enforceable duty or contain any 
    unfunded mandate as described under Title II of the Unfunded Mandates 
    Reform Act of 1995 (UMRA) (Pub.L. 104-4). Nor does it require any 
    special considerations as required by Executive Order 12898, entitled 
    Federal Actions to Address Environmental Justice in Minority 
    Populations and Low-Income Populations (59 FR 7629), February 16, 
    1994), or require OMB review in accordance with Executive Order 13045, 
    entitled Protection of Children from Environmental Health Risks and 
    Safety Risks (62 FR 19885, April 23, 1997).
        In additions, since tolerance exemptions that are established on 
    the basis of a petition under FFDCA section 408(d), such as the 
    exemption in this final rule, do not require the issuance of a proposed 
    rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
    U.S.C. 601 et seq.) do not apply. Nevertheless, the Agency previously 
    assessed whether establishing tolerances, exemptions from tolerances, 
    raising tolerance levels or expanding exemptions might adversely impact 
    small entities and concluded, as a generic matter, that there is no 
    adverse economic impact. The factual basis for the Agency's generic 
    certification for tolerance actions published on May 4, 1981 (46 FR 
    24950), and was provided to the Chief Counsel for Advocacy of the Small 
    Business Administration.
    
    B. Executive Order 12875
    
        Under Executive Order 12875, entitled Enhancing the 
    Intergovernmental Partnership (58 FR 58093, October 28, 1993), 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. If the mandate is unfunded, EPA 
    must provide to OMB 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 an unfunded Federal mandate on 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.
    
    C. Executive Order 13084
    
        Under Executive Order 13084, entitled Consultation and Coordination 
    with Indian Tribal Governments (63 FR 27655, May 19, 1998), 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. If the 
    mandate is unfunded, EPA must provide OMB, 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 action does not involve 
    or impose any requirements that affect Indian tribes. Accordingly, the 
    requirements of section 3(b) of Executive Order 13084 do not apply to 
    this rule.
    
    X. Submission to Congress and the Comptroller General
    
        The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
    Small Business Regulatory Enforcement Fairness Act of 1996, generally 
    provides that before a rule may take effect, the agency promulgating 
    the rule must submit a rule report, which includes a copy of the rule, 
    to each House of the Congress and to the Comptroller General of the 
    United States. EPA will submit a report containing this rule and other 
    required information to the U.S. Senate, the U.S. House of 
    Representatives and the Comptroller General of the United States prior 
    to publication of the rule in the Federal Register. This is not a 
    ``major rule'' as defined by 5 U.S.C. 804(2).
    
    List of Subjects in 40 CFR Part 180
    
        Environmental protection, Administrative practice and procedure, 
    Agricultural commodities, pesticides and pests, Reporting and 
    recordkeeping requirements.
    
        Dated: December 21, 1998.
    
    James Jones,
    Director, Registration Division, Office of Pesticide Programs.
    
        Therefore, 40 CFR chapter I is amended as follows:
    
    PART 180--[AMENDED]
    
        1. The authority citation for part 180 continues to read as 
    follows:
        Authority: 21 U.S.C. 346a and 371.
    
    Sec. 180.1001  [Amended]
    
        2. Section 180.1001 in subpart D is amended in paragraph (b)(1), by 
    adding alphabetically ``copper-ethylenediamine complex,''.
    
    [FR Doc. 98-34702 Filed 12-31-98; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Effective Date:
2/3/1999
Published:
01/04/1999
Department:
Environmental Protection Agency
Entry Type:
Rule
Action:
Final rule.
Document Number:
98-34702
Dates:
This regulation is effective February 3, 1999. Objections and requests for hearings must be received by EPA on or before March 5, 1999.
Pages:
41-44 (4 pages)
Docket Numbers:
OPP-300777, FRL-6052-5
RINs:
2070-AB78
PDF File:
98-34702.pdf
CFR: (1)
40 CFR 180.1001