94-10138. Hearing Concerning Application To Modify the Final Cancellation Order for Pesticide Products Containing EBDCs  

  • [Federal Register Volume 59, Number 81 (Thursday, April 28, 1994)]
    [Unknown Section]
    [Page ]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 94-10138]
    
    
    [Federal Register: April 28, 1994]
    
    
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    Part IX
    
    
    
    
    
    Environmental Protection Agency
    
    
    
    
    
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    Hearing Concerning Application To Modify the Final Cancellation Order 
    for Pesticide Products Containing EBDCs; Notice
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    ENVIRONMENTAL PROTECTION AGENCY
    
    [OPP-30000/18E; FRL-4773-3]
    
    
    Hearing Concerning Application To Modify the Final Cancellation 
    Order for Pesticide Products Containing EBDCs
    
    AGENCY: Environmental Protection Agency (EPA).
    
    ACTION: Notice of Hearing.
    
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    SUMMARY: On December 1, 1993 the Agency received a request from Elf 
    Atochem and Griffin Corporations to amend labels of certain pesticide 
    products which contain the active ingredients of mancozeb or maneb and 
    which were affected by the final EBDC Cancellation Order and to modify 
    the final EBDC Cancellation Order to allow all EBDC registrants to 
    modify their end use product label(s) in the same manner that Atochem 
    and Griffin have proposed to amend theirs. The proposed amendment seeks 
    to allow the use of more than one EBDC active ingredient per crop per 
    season. It also seeks to allow for a single application per crop per 
    season for seed treatment in addition to any foliar uses for products 
    which have a registered seed treatment use for the particular crop. The 
    proposed amendments would not change the current maximum allowable 
    amount of EBDCs.
        Under subpart D of 40 CFR Part 164, this submission constitutes a 
    petition to modify the final cancellation order concerning EBDC 
    products. Such a petition may not be granted without a formal 
    adjudicatory hearing. EPA has concluded that the submissions by Atochem 
    and Griffin, if substantiated in a hearing, may provide a basis for 
    modification of the order canceling EBDC products. This Notice (1) 
    announces that EPA has decided to hold a hearing regarding the petition 
    to modify that order as it applies to the use of more than one EBDC 
    active ingredient per crop per season and the allowance of a single 
    application for seed treatment per crop per season (in addition to 
    foliar applications) on crops which have registered seed treatment 
    uses, (2) specifies the issues of fact and law to be considered at that 
    hearing, and (3) establishes a schedule for the hearing.
    
    DATES: Requests to participate in the hearing announced by this notice 
    must be received by the Office of the Hearing Clerk at the address 
    given below by [insert date 30 days after date of publication in the 
    Federal Register]. A pre-hearing conference will be held and the 
    evidentiary hearing will commence as soon thereafter as practicable, 
    according to the schedule outlined herein.
    
    ADDRESSES: Requests for a hearing must be submitted to: Hearing Clerk 
    (1900), Environmental Protection Agency, 401 M St., SW., Washington, DC 
    20460. Information supporting the Administrator's decision to hold a 
    hearing will be available for public inspection from 8 a.m. to 4 p.m., 
    Monday through Friday, except legal holidays in: Information Services 
    Section, Management and Program Support Division (7502C), Office of 
    Pesticide Programs, Environmental Protection Agency, Room 236, Crystal 
    Mall #2, 1921 Jefferson Davis Highway, Arlington, VA.
    
    FOR FURTHER INFORMATION CONTACT: By mail: Amy Farrell, Special Review 
    and Reregistration Division (7508W), Office of Pesticide Programs, 
    Environmental Protection Agency, 401 M St., SW., Washington, DC 20460. 
    Office location and telephone number: Crystal Station, 2800 Jefferson 
    Davis Highway, Arlington, VA (703) 308-8054.
    
    SUPPLEMENTARY INFORMATION: On March 2, 1992, the Administrator issued a 
    Notice of Intent to Cancel (NOITC) and Conclusion of the EBDC Special 
    Review which announced EPA's intent to cancel registrations and to deny 
    applications for registration for all pesticide products containing 
    EBDCs as an active ingredient unless the registrations/applications 
    complied with the terms and conditions of that Notice. As a result of 
    the Notice, 11 uses were canceled and use restrictions were placed on 
    the remaining 45 uses. One requirement was that, to avoid cancellation, 
    all EBDC labels and product registrations bearing agricultural uses 
    must be amended to include the following label statement: ``If this 
    product is used on a crop, no other product containing a different EBDC 
    active ingredient may be used on the same crop during the same growing 
    season.'' This requirement prohibits the use of more than one EBDC 
    active ingredient per crop per season.
    
    I. The Submissions
    
        On December 1, 1993 the Agency received evidentiary submissions 
    from Elf Atochem and Griffin Corporations in support of their requests: 
    (1) To amend labels of seven EBDC pesticide products which were subject 
    to the Cancellation Order and which contain the active ingredients of 
    mancozeb or maneb (ManexTM, Maneb 75DF, Maneb 80, Maneb Plus Zinc 
    F4, Penncozeb, Penncozeb DF and Pro-Tex) and (2) that the Agency modify 
    the final EBDC Cancellation Order to allow all other EBDC registrants 
    to modify their EBDC end use product label(s) in the same manner that 
    Atochem and Griffin have proposed to amend theirs. Subsequently, 
    additional related correspondence was submitted by Atochem and Griffin 
    on December 30, 1993 and January 12, 1994 to supplement the original 
    proposal.
        The current label language required by the Cancellation Order 
    prohibits the use of more than one EBDC (maneb, mancozeb, or metiram) 
    on a given crop during a growing season. The petitioners request that 
    more than one EBDC active ingredient be allowed to be used per crop per 
    season. Under their proposal, when all products being used have the 
    same maximum poundage (maximum application rate times the maximum 
    number of allowed applications) the total amount used must not exceed 
    the maximum label poundage, or when the products being used have 
    different maximum poundages, the total amount used must not exceed the 
    lowest maximum poundage. Additionally, allowance for a single seed 
    treatment in addition to foliar applications where there is a 
    registered use for seed treatment is requested.
        In their request, Atochem and Griffin are asking that EPA modify 
    the Cancellation Notice and Order as noted below so that any EBDC 
    registrant may amend their labels accordingly. The request also 
    includes applications to amend labels of seven mancozeb and maneb 
    products.
        One of the elements of the Cancellation Notice and Order was a 
    label requirement which reads ``If this product is used on a crop, no 
    other product containing a different EBDC active ingredient may be used 
    on the same crop during the same growing season.'' This current 
    language prevents the use of more than one EBDC active ingredient per 
    crop per season. The registrants are proposing to replace that language 
    with the following language:
    
        Foliar applications. Where EBDC products used allow the same 
    maximum poundage of active ingredient per acre per season:
    
        If more than one product containing an EBDC active ingredient 
    (maneb, mancozeb, or metiram) is used on a crop during the same 
    growing season and the EBDC products used allow the same maximum 
    poundage of active ingredient per acre per season, then the total 
    poundage of all such EBDC products used must not exceed any of the 
    specified individual EBDC product maximum seasonal poundage of 
    active ingredient allowed per acre.
    
    
        Where EBDC products used allow different maximum poundage of active 
    ingredient per acre per season:
    
        If more than one product containing an EBDC active ingredient is 
    used on a crop during the same growing season and the EBDC products 
    used allow different maximum poundage of active ingredient per acre 
    per season, then the total poundage of all such EBDC products used 
    must not exceed the lowest specified individual EBDC product maximum 
    seasonal poundage of active ingredient allowed per acre.
    
    
        Seed Treatment
    
        In addition to the maximum number of foliar applications 
    permitted by the formula stated above, a single application for seed 
    treatment may be made on crops which have registered seed treatment 
    uses.
    
    
        The language proposed by the registrants allows the use of more 
    than one EBDC active ingredient per crop per season, specifies formulas 
    to follow for maximum poundage allowed when different EBDCs are used, 
    and allows for a single seed treatment per crop per season in addition 
    to the foliar applications where the crop has a registered seed 
    treatment use.
    
    II. Regulatory History
    
        On March 2, 1992, the Administrator issued a Notice of Intent to 
    Cancel (NOITC) and Conclusion of the EBDC Special Review which 
    announced EPA's intent to cancel registrations and to deny applications 
    for registration for all pesticide products containing EBDCs as an 
    active ingredient unless the registrations/applications complied with 
    the terms and conditions of that Notice. The decision to issue that 
    order was based on the determination that use of EBDCs without such 
    modified terms and conditions would result in unreasonable adverse 
    effects to humans or the environment. More specifically, 11 uses were 
    canceled and use restrictions placed on the remaining 45 uses. The 
    information and analysis upon which that determination was based is set 
    forth in detail in the text of the March 2, 1992 NOITC (57 FR 7484).
        The NOITC contained a requirement that, to avoid cancellation, all 
    EBDC labels and product registrations bearing agricultural uses must be 
    amended to include the following label statement: ``If this product is 
    used on a crop, no other product containing a different EBDC active 
    ingredient may be used on the same crop during the same growing 
    season.'' This requirement prohibits the use of more than one EBDC 
    active ingredient per crop per season. Although the reason for this 
    requirement was not stated in the Notice, the Agency's decision to 
    limit EBDC application as such was to avoid the potential overuse of 
    EBDC's through active ingredient switching. The decision was not based 
    on specific risk concerns or on the risk calculations underlying the 
    Agency's EBDC regulatory decision.
        Subsequent to the NOITC becoming an effective order of 
    cancellation, the Agency received a request for a subpart D hearing, 
    the evidentiary submissions and associated correspondence from Elf 
    Atochem and Griffin Corporations, the details of which are delineated 
    above. The Agency received supporting letters from the Florida Fruit 
    and Vegetable Association and the National Potato Council. The language 
    proposed would replace a label requirement specified in the 
    Cancellation Notice and Order which allows the use of only one EBDC per 
    crop per season and prohibits certain seed treatment applications.
    
    III. Statutory and Regulatory Background
    
    A. Standards for Maintaining a Registration
    
        Before a pesticide product may be lawfully sold or distributed in 
    either intrastate or interstate commerce, the product must be 
    registered by the Environmental Protection Agency. FIFRA section 3(a) 
    and 12(a)(1)(A). A registration is a license allowing a pesticide 
    product to be sold and distributed for specified uses in accordance 
    with specified use instructions, precautions, and other terms and 
    conditions. A pesticide product may be registered or remain registered 
    only if it performs its intended pesticidal function without causing 
    ``unreasonable adverse effects on the environment'' FIFRA section 
    3(c)(5). ``Unreasonable adverse effects on the environment'' is defined 
    as ``any unreasonable risk to man or the environment, taking into 
    account the economic, social, and environmental costs and benefits of 
    the use of the pesticide.'' FIFRA section 2(b). The burden to 
    demonstrate that a pesticide product satisfies the criteria for 
    registration is on the proponents of initial or continued registration. 
    Industrial Union Dept. v. American Petroleum Institute, 448 U.S. 607, 
    653 n.61 (1980); Environmental Defense Fund v. Environmental Protection 
    Agency, 510 F.2d 1292, 1297, 1302 (D.C. Cir. 1975).
        Under FIFRA section 6, the Agency may issue a notice of intent to 
    cancel the registration of a pesticide product whenever it is 
    determined that the product no longer satisfies the statutory criteria 
    for registration. The Agency may specify particular modifications in 
    the terms and conditions of registration, such as deletion of 
    particular uses or revisions of labeling, as an alternative to 
    cancellation. If a hearing is requested by an adversely affected 
    person, the final order concerning cancellation of the product is not 
    issued until after a formal administrative hearing.
    
    B. Subpart D Proceedings
    
        When the Agency receives an application to permit use of a 
    pesticide in a manner inconsistent with a prior cancellation decision, 
    that application constitutes a petition to the Administrator to modify 
    the final cancellation order. Because of the opportunity for a notice 
    and a formal adjudicatory hearing which precedes entry of a final 
    cancellation order concerning a pesticide product, EPA has determined 
    that such an order should not be modified or rescinded without 
    affording interested parties a similar notice and opportunity for 
    hearing concerning such modification or rescission. The procedures 
    governing all applications to modify or reverse a previous final 
    cancellation order are set forth in subpart D of 40 CFR part 164, 40 
    CFR 164.130 through 164.133.
        When all opportunities for hearing and review with respect to an 
    Agency decision to cancel a pesticide product have either been 
    exercised or waived, and a final cancellation order has been entered, 
    the Agency is entitled to rely on the finality of the order and the 
    validity of the evidentiary rationale supporting it. Applicants seeking 
    modification of a final order should not be afforded a new adjudicatory 
    hearing concerning the same matters which were considered or could have 
    been considered during a prior hearing. Thus, 40 CFR 164.131(a) 
    provides that the Administrator will grant a hearing to modify a prior 
    final cancellation order when she finds that:
        (1) The applicant has presented substantial new evidence which may 
    materially affect the prior cancellation order and which was not 
    available to the Administrator at the time he/she made his/her final 
    cancellation determination and, (2) such evidence could not, through 
    the exercise of due diligence, have been discovered by the parties to 
    the cancellation proceeding prior to the issuance of the final order.
        In deciding whether or not to initiate a hearing, the Administrator 
    does not need to determine that the evidence submitted by the 
    petitioner would in fact justify modification of the prior order. 
    Rather, a decision to initiate a hearing means only that the 
    Administrator has determined that the evidence submitted, if 
    substantiated on the record in the hearing, may ``materially affect'' 
    the evidentiary rationale upon which the prior order was based. On the 
    other hand, if the evidence submitted, even if substantiated on the 
    record, would be unlikely to provide a basis for modification of the 
    prior order, then a hearing would serve no purpose.
        If the Administrator determines that a petitioner has met the 
    criteria for a subpart D hearing, the Administrator then publishes a 
    notice in the Federal Register setting forth the determination, the 
    rationale for that determination, a description of the issues of fact 
    and law to be adjudicated in the hearing, and a schedule for the 
    hearing. The purpose of the hearing is to determine whether: (1) 
    Substantial new evidence exists and (2) such substantial new evidence 
    requires reversal or modification of the existing cancellation order. 
    For purposes of any decision in the hearing, those portions of the 
    substantive rationale for the existing order concerning which the 
    petitioner did not submit substantial new evidence are assumed to be 
    correct. Thus, the scope of any subpart D hearing is intrinsically 
    narrower than the proceeding which was held or could have been held 
    concerning the order to be modified.
        In a subpart D hearing, as in a cancellation hearing, the 
    Administrative Law Judge transmits a recommended decision to the 
    Administrator, who then issues a final decision retaining, modifying, 
    or reversing the existing order.
    
    IV. Analysis of the EBDC Request for Subpart D Hearing
    
    A. Risk Issues
    
        Atochem and Griffin have not submitted any new information which 
    would affect the validity of the Agency's analysis of the toxicity of 
    EBDCs or the methodology used by the Agency to estimate exposure to 
    EBDCs. The petitioners assert that the proposed language does not 
    increase the individual or seasonal application limits and provides 
    equivalent protection in terms of limiting exposure while addressing 
    the Agency's concerns about multiple EBDC use and having the added 
    advantage of being more easily understood. The petitioners further 
    assert that the decision to restrict EBDC use as per the restrictive 
    language of the NOITC was not based on specific risk concerns but on 
    concerns of exceeding maximum amount of product allowed per crop per 
    season.
        As mentioned in unit II above, the March 2, 1992 NOITC, which 
    contained the requirement which would prevent the use of more than one 
    EBDC active ingredient per crop per season, did not provide a risk/
    benefit rationale for the specific application prohibitions at issue 
    here. The Agency's thinking at that time was that such a provision 
    would help assure that growers would not exceed EBDC usage limits per 
    crop. The language was designed to address this need. There are other 
    disincentives to growers that should dissuade them from engaging in 
    that type of practice, such as the risk of having crops with over-
    tolerance residues which could make crops subject to seizure.
        The Agency recognizes that there might be different and better ways 
    to address this concern which do not increase risks and would allow 
    EBDC use in situations where multiple EBDC use is warranted.
    
    B. Benefits Issues
    
        The Atochem and Griffin submission includes information and 
    evidence on the benefits of using more than one EBDC active ingredient 
    per crop per season which was not available to or considered by the 
    Agency prior to the final Cancellation Order. The submission asserts 
    that the current label restriction ``has had a substantial impact on 
    the industry, including negative effects on competition, industry-wide 
    confusion, and hardship for suppliers and growers alike'' and includes 
    information which is summarized below in support of their assertion:
        The current label specification precludes growers from switching 
    among EBDCs for any reason. This is true even if a particular product 
    is high priced due to limited availability or unavailable altogether.
        The petitioners assert that the potato industry has faced a unique 
    problem. According to petitioners, many potato growers are required by 
    contract with food processors or packers to make pre-storage 
    applications of Ridomil (metalaxyl) which contains mancozeb, 
    because consultants and researchers have strongly recommended this as a 
    way to prevent root rot, or late blight. This, coupled with the current 
    prohibition on switching among EBDC active ingredients, precludes any 
    potato grower under such a contract from using any EBDC but mancozeb on 
    that crop for the remainder of the season--even though it may not be 
    the most effective treatment for the pest. Petitioners further assert 
    that there is an increased risk of resistance when the range of 
    products used is limited.
        Fungal problems associated with potatoes include root rot, or late 
    blight which is commonly treated with a metalaxyl product which is 
    considered most effective when it is a metalaxyl/EBDC mix. Product 
    mixes (as opposed to tank mixes) are preferred because of their 
    convenience, ease in handling, reduced potential exposure, and reduced 
    costs. Current labeling precludes growers from using metalaxyl/EBDC 
    mixes such as Ridomil Mz (metalaxyl and mancozeb) if they had 
    used maneb earlier in the season. This would limit them to using 
    metalaxyl without an EBDC which may be a less effective treatment and 
    may limit the potatoes' marketability.
        Reliability of supply is another issue that growers consider. All 
    EBDC active ingredients are manufactured abroad and domestic suppliers 
    have little control over ensuring their steady supply. The failure of a 
    foreign supplier or manufacturer to deliver the active ingredients as 
    scheduled can result in the shortage of a particular formulation. This 
    could create problems for growers who are bound by current label 
    specifications to the use of a specific active ingredient.
        The submission provides some evidence of the registrant/
    marketplace/grower confusion that resulted from implementation of this 
    provision that was not available at the time of the NOITC. The 
    submission asserts that there has been significant confusion in the 
    marketplace and among growers and includes two examples: the Wisconsin 
    Potato and Vegetable Growers Association, according to their February 
    8, 1993 newsletter, interpreted the current label language to restrict 
    growers to one brand all season and Sugar Producer Magazine interpreted 
    the statement the same way, saying that no product switching would be 
    allowed.
        These interpretations of the language differ substantially from the 
    EPA's post-cancellation order interpretation (EPA response to questions 
    posed by the EBDC/ETU Task Force after the NOITC had become a final 
    cancellation order) which clearly limited only switching among active 
    ingredients and did not restrict switching among different brands of 
    the same EBDC active ingredient. Petitioners assert that this confusion 
    could influence purchasing decisions and create unfair advantages for 
    certain products while undermining integrated pest control practices.
        As noted above, the Agency has attempted to clarify this issue, but 
    even with clarification, the unintended impacts have continued. The 
    Agency recognizes that the label language required by the NOITC has 
    created confusion and implementation problems in the marketplace and at 
    the grower level. It is obvious from the information provided by the 
    Petitioners that this confusion has continued even after the Agency 
    attempted to clarify the requirement and its intent. Obviously, the 
    Agency does not want this confusing situation to continue. In light of 
    the unfortunate situation that has evolved since the NOITC requirement 
    became final and began to be implemented, the Agency now believes that 
    its goal of limiting the potential exceeding of EBDC usage limits by 
    growers can be addressed in a better way with different label language.
        Atochem and Griffin further assert that the current label 
    restriction is inconsistent with the nature of Integrated Pest 
    Management (IPM) programs which are ``based on selective use of 
    different classes of fungicides...''
        The Agency has received copies of correspondence from the Florida 
    Fruit and Vegetable Association and the National Potato Council 
    discussing certain problems faced by growers who are bound by the 
    current label restrictions. Both letters expressed strong support for 
    the Atochem and Griffin request to replace the current restriction with 
    the proposed language.
        The Atochem and Griffin submission asserts that ``the proposed 
    language serves EPA's objective which was to ensure that seasonal 
    limits on the quantities of EBDCs that can be applied to a particular 
    crop not be exceeded without any negative effects on competition or any 
    hardship to the industry or to growers.''
    
    C. Subpart D Determination
    
        Under 40 CFR 164.131(a), the Administrator is to provide a hearing 
    to modify a prior final cancellation decision only if it is determined 
    that certain criteria have been met. Having concluded that Atochem and 
    Griffin have presented substantial new evidence concerning the impact 
    of new restrictions on the use of more than one EBDC active ingredient 
    per crop per season which was not available to the Agency when the 
    final cancellation order went into effect, the Administrator must now 
    determine whether that evidence ``may materially affect'' that order. 
    The Administrator has concluded that because risk will not be increased 
    by adoption of the proposed language, she might consider modifying the 
    cancellation decision to alter this restriction if the evidentiary 
    record in a hearing substantiates the Atochem and Griffin assertions 
    concerning the impacts of the restrictions and the benefits of using 
    more than one EBDC active ingredient per crop per season and in certain 
    cases allowing a single seed treatment application per crop per season 
    in addition to foliar applications. Thus, the first criterion in 40 CFR 
    164.131(a) has been met.
        Certain information provided by Petitioners on the post-
    cancellation order implementation confusion, and problems created by 
    this label provision in the marketplace and among users, could not have 
    reasonably been obtained before the restriction was in place. Having 
    also concluded that either these petitioners or the parties in the 
    cancellation proceeding could not have discovered earlier some of this 
    new evidence on the impact of this restriction ``through the exercise 
    of due diligence'' the second criterion in 40 CFR 164.131(a) has also 
    been met.
        Based on the above analysis, the Administrator has decided to hold 
    a hearing under subpart D to consider whether to modify the final 
    cancellation order for pesticide products containing EBDCs as it 
    applies to the restriction on the use of more than one EBDC active 
    ingredient per crop per season and the allowance in certain cases of a 
    single seed treatment application per crop per season in addition to 
    foliar applications.
    
    V. Hearing Procedures
    
    A. Issues To Be Adjudicated
    
        Pursuant to 40 CFR 164.131(c), the Administrator is specifying 
    those issues of fact and law to be adjudicated in the hearing convened 
    pursuant to this notice. Because the purpose of such a hearing is only 
    to consider whether to modify certain aspects of the Administrator's 
    prior cancellation decision and because a prompt conclusion to the 
    hearing is a requisite of meaningful relief for the petitioners, the 
    evidentiary presentation in the hearing shall be strictly confined to 
    the issues of fact and law which the Administrator has determined are 
    presented by the Atochem and Griffin submission.
        The issues of fact to be adjudicated are:
        1. What will the economic impacts on growers, processors, and 
    consumers be if the lack of a provision for a seed treatment 
    application and the present restriction on using multiple EBDC active 
    ingredients on the same crop during the same growing season continue?
        2. What have been the use practices regarding the use of more than 
    one EBDC active ingredient per crop per season prior to the current 
    restriction?
        3. What will be the effect of the present restriction on using 
    multiple EBDC active ingredients on the same crop during the same 
    growing season if this restriction is maintained? Likewise, what would 
    be the effect on efficacy of EBDC use and other pest control practices 
    if the lack of a provision for a seed treatment application continues?
        4. Assuming the validity of the analysis of the toxicity of EBDCs 
    and the methodology for analysis of exposure to EBDCs upon which the 
    cancellation order was based, what quantitative effect would adoption 
    of the proposed language have on the total risk associated with EBDC 
    use?
        The issues of law to be adjudicated are:
        1. Has substantial new evidence been presented pertaining to the 
    use of more than one EBDC active ingredient per crop per season and 
    allowance in certain cases for a single seed treatment application per 
    crop per season in addition to foliar applications and the impact of 
    the current restriction?
        2. Assuming the validity of the analysis of the toxicity of EBDCs 
    and the methodology for analysis of exposure to EBDCs upon which the 
    cancellation order was based, does the evidence presented demonstrate 
    that the benefits of allowing use of more than one EBDC active 
    ingredient per crop per season and allowing in certain cases a single 
    seed treatment application per crop per season in addition to foliar 
    applications are likely to outweigh the risks of such use? [i.e. Based 
    on the evidence presented, should the Agency revise its prior 
    determination that allowed use to be limited to one active ingredient 
    per crop per season and that a single seed treatment should not be 
    allowed in certain cases in addition to the foliar application?]
        The sole objective of this hearing is to determine whether or not 
    the order canceling all sale, distribution, and use of pesticide 
    products containing EBDCs which do not comply with the current label 
    restriction on multiple EBDC use should be modified to permit the use 
    of more than one EBDC active ingredient per crop per season and allow a 
    single seed treatment in addition to foliar uses where there is a 
    registered seed treatment use.
    
    B. Burden of Proof
    
        As provided by 40 CFR 164.132, the burden of proof in this 
    proceeding shall be on the proponent(s) of modification of the final 
    cancellation order and the petitioners shall proceed first. As in all 
    formal adjudication, all testimony must be presented and documents 
    sponsored by a witness competent to be cross-examined on the material. 
    It is the petitioners rather than the Agency who must make an 
    evidentiary record substantiating the assertions in the submission. Of 
    course, Agency counsel may also present testimony and cross-examine 
    Petitioners' witnesses concerning the issues of fact to be adjudicated.
    
    C. Hearing Requests
    
        The petitioners and the Agency shall automatically be parties in 
    the hearing. Any other person or party who seeks to participate in the 
    hearing must submit a written hearing request describing the interest 
    of that person or party in the proceeding and the nature and purpose of 
    the participation sought. All requests for a hearing must be received 
    by the Office of the Hearing Clerk within 30 calendar days from the 
    date of publication of this Notice in the Federal Register. Any request 
    received after that time will be denied. Requests for a hearing must be 
    submitted to: Hearing Clerk (1900). Environmental Protection Agency, 
    401 M St., SW., Washington, DC 20460.
    
    D. Scheduling
    
        As required by 40 CFR 164.131(c), the Administrator is specifying a 
    schedule for this hearing. In recognition of the narrow scope of the 
    proceeding, the Administrator is establishing the following schedule.
        The Chief Administrative Law Judge shall appoint an Administrative 
    Law Judge to preside at this proceeding within 35 calendar days from 
    date of publication of this Notice in the Federal Register. The hearing 
    shall commence in Washington, DC as soon thereafter as practicable but 
    in no event later than 40 calendar days from the date of publication of 
    this Notice in the Federal Register. The presiding Administrative Law 
    Judge shall transmit recommended findings of fact and conclusions of 
    law and the hearing record to the Administrator within 70 calendar days 
    from the date of publication of this Notice in the Federal Register. 
    The parties shall submit any objections to the recommended findings of 
    fact and conclusions of law to the Administrator within 10 business 
    days after issuance, and the Administrator will enter a final order as 
    soon thereafter as practicable.
    
    E. Separation of Functions
    
        EPA's Rules of Practice forbid anyone who may take part in deciding 
    this case at any stage of the proceeding, from discussing the merits of 
    the proceeding ex parte with any party or with any person who has been 
    connected with the preparation or presentation of the proceeding as an 
    advocate or in any investigative or expert capacity, or with any of 
    his/her representatives (40 CFR 164.7).
        Accordingly, the following EPA offices, and the staffs thereof, are 
    designated as the judicial staff of EPA in any administrative hearing 
    on this issue: the Office of Administrative Law Judges, the 
    Environmental Appeals Board, the Deputy Administrator, and the members 
    of the staff in the immediate office of the Deputy Administrator, and 
    the Administrator and the members of staff in the immediate office of 
    the Administrator. The following offices are designated as the trial 
    staff in any proceeding which may arise under this Notice: The Office 
    of General Counsel, the Assistant Administrator for the Office of 
    Prevention, Pesticides, and Toxic Substances and immediate staff, the 
    Office of Pesticide Programs, and the Office of Compliance Monitoring. 
    None of the persons designated as the judicial staff may have any ex 
    parte communications with the trial staff or any other interested 
    person not employed by EPA on the merits of any of the issues involved 
    in this proceedings, without fully complying with the applicable 
    regulations.
    
        Dated: April 18, 1994.
    
    Lynn R. Goldman,
    Assistant Administrator for Prevention, Pesticides and Toxic 
    Substances.
    
    [FR Doc. 94-10138 Filed 4-26-94; 8:45 am]
    BILLING CODE 6560-50-F
    
    
    

Document Information

Published:
04/28/1994
Department:
Environmental Protection Agency
Entry Type:
Uncategorized Document
Action:
Notice of Hearing.
Document Number:
94-10138
Dates:
Requests to participate in the hearing announced by this notice
Pages:
0-0 (None pages)
Docket Numbers:
Federal Register: April 28, 1994, OPP-30000/18E, FRL-4773-3