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40 CFR Part 164 — Rules of Practice Governing Hearings, Under the Federal Insecticide, Fungicide, and Rodenticide Act, Arising from Refusals to Register, Cancellations of Registrations, Changes of Classifications, Suspensions of Registratio

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PART 164—RULES OF PRACTICE GOVERNING HEARINGS, UNDER THE FEDERAL INSECTICIDE, FUNGICIDE, AND RODENTICIDE ACT, ARISING FROM REFUSALS TO REGISTER, CANCELLATIONS OF REGISTRATIONS, CHANGES OF CLASSIFICATIONS, SUSPENSIONS OF REGISTRATIONS AND OTHER HEARINGS CALLED PURSUANT TO SECTION 6 OF THE ACT Authority: 7 U.S.C. 136d. Source: 38 FR 19371, July 20, 1973, unless otherwise noted. Subpart A—General § 164.1 Number of words. As used in this part, a word in the singular form shall be deemed to import the plural, and vice versa, as the case may require. § 164.2 Definitions. For the purposes of this part, the following terms shall be defined, as listed below: (a) The term Act (b) The term Administrative Law Judge (c) The term Administrator (d) The term Agency, (e) The term Applicant (f) The term Committee (g) Environmental Appeals Board (h) The term Expedited Hearing (i) The term Hearing (j) The term Hearing Clerk (k) The term Initial Decision (l) The term Judicial Officer (1) Office. (2) Qualification. (3) Functions. (m) The term Party (n) The term Person (o) The term Petitioner (p) The term Presiding Officer (q) The term Recommended Decision (r) The term Registrant (s) The term Respondent Terms defined in the act and not explicitly defined herein are used herein with the meanings given in the act. [38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992; 57 FR 30657, July 10, 1992; 73 FR 75597, Dec. 12, 2008; 77 FR 46292, Aug. 3, 2012] § 164.3 Scope and applicability of this part. The provisions of subpart B of this part shall govern proceedings, conducted pursuant to the provisions of the Act, concerning refusals to register, cancellations of registration, changes of classifications or hearings called by the Administrator; the provisions of subpart C of this part shall govern suspension proceedings conducted pursuant to the provisions of the Act. § 164.4 Arrangements for examining Agency records, transcripts, orders, and decisions. (a) Reporting of orders, decisions, and other signed documents. (b) Establishment of an Agency repository. (c) Whenever any information or data is required to be produced or examined and any party to the proceeding claims that such information is a trade secret or commercial or financial information, other than information relating to the formulas of a pesticide, the Administrative Law Judge, the Presiding Officer, or the Environmental Appeals Board may require production or testimony in camera (d) All orders, decisions, or other documents made or signed by the Administrative Law Judge, the Presiding Officer, or the Environmental Appeals Board shall be filed with the hearing clerk. The hearing clerk shall immediately serve all parties with a copy of such order, decision, or other document. [38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992] § 164.5 Filing and service. (a) All documents or papers required or authorized to be filed, shall be filed with the hearing clerk, except as provided otherwise in this part. At the same time that a party files documents or papers with the clerk, it shall serve upon all other parties copies thereof, with a certificate of service on each document or paper, including those filed with the hearing clerk. If filing is accomplished by mail addressed to the clerk, filing shall be deemed timely if the papers are postmarked on the due date except as to initial filings requesting a public hearing or responding to a notice of intent to hold a hearing, in which case such filings must be received by the hearing clerk either within the time required by statute or by the notice of intent to hold a hearing. (b) Each document filed, other than papers commencing a proceeding, shall contain the FIFRA docket number and, if the document affects less than all of the registrations included under that docket number, the registration number or file symbol of each product which is the subject of the document. (c) In addition to copies served on all other parties, each party shall file an original and two copies of all papers with the hearing clerk. § 164.6 Time. (a) Computation. (b) Enlargement. (c) Additional time after service by mail. [38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992] § 164.7 Ex parte discussion of proceeding. At no stage of a proceeding shall the Administrator, the members of the Environmental Appeals Board, the Presiding Officer, or the Administrative Law Judge discuss ex parte Provided, [57 FR 5342, Feb. 13, 1992] § 164.8 Publication. All notices of intention to cancel a registration, all notices of intention to change a classification, and all denials of registrations, all together with the reasons (including the factual basis therefor), and all notices of intention by the Administrator to hold a hearing, together with the statement of issues as provided by § 164.20(b) shall be sent to the registrant or applicant by registered or certified mail (return receipt requested), and published by appropriate announcement in the Federal Register Federal Register et seq. Federal Register, Subpart B—General Rules of Practice Concerning Proceedings (Other Than Expedited Hearings) Commencement of Proceeding § 164.20 Commencement of proceeding. (a) A proceeding shall be commenced whenever a hearing is requested by any person adversely affected by a notice of the Administrator of his refusal to register or of his intent to cancel the registration or to change the classification of a pesticide. A proceeding shall likewise be commenced whenever the Administrator decides to call a hearing to determine whether or not the registration of a pesticide should be canceled or its classification changed. Such request or notice of intent to hold a hearing shall be timely filed with the hearing clerk, and the matter shall be docketed and assigned a FIFRA docket number. (b) If a request for a hearing is filed, the person filing the request shall, at the same time, file a document stating his objections to the Administrator's refusal to register or his intent to cancel the registration or to change the classification of a pesticide. If a notice of intent to hold a hearing is filed by the Administrator, he shall, at the same time, file a statement of issues. (c) Upon the filing of any objections or notice of intent to hold a hearing, the proceeding shall be referred to the Chief Administrative Law Judge by the hearing clerk. The Chief Administrative Law Judge shall refer the proceeding to himself or another Administrative Law Judge who shall thereafter be in charge of all further matters concerning the proceedings, except as otherwise provided for by order of the Chief Administrative Law Judge, the Administrator, or the Environmental Appeals Board. [38 FR 19371, July 20, 1973, as amended at 38 FR 34117, Dec. 11, 1973; 57 FR 5342, Feb. 13, 1992] § 164.21 Contents of a denial of registration, notice of intent to cancel a registration, or notice of intent to change a classification. (a) Contents. (b) Amendments to contents of denials and notices. § 164.22 Contents of document setting forth objections. (a) Concise statement required. (b) Amendments to objections byleave. (c) Amendments to objections as a matter of right. § 164.23 Contents of the statement of issues to accompany notice of intent to hold a hearing. (a) Concise statement required. (b) Amendment to statement of issues. § 164.24 Response to the Administrator's notice of intention to hold a hearing. Any person wishing to participate in any proceeding commenced pursuant to any notice by the Administrator of intention to hold a hearing, shall file with the hearing clerk, within the time set by the Administrator in the notice (in no case less than 30 days from the date of the notice), a written response to the statement of issues which shall include the position and interest of such person with respect thereto. If any such person is a registrant or an applicant for registration, he shall also file the registration number of the pesticide, if applicable, a copy of the currently accepted and/or proposed labeling and a list of the currently registered or proposed uses of said pesticide. § 164.25 Filing copies of notification of intent to cancel registration or change classification or refusal to register, and statement of issues. After a copy of the document setting forth the objections and requesting a public hearing is filed with the hearing clerk or a response to the statement of issues is filed, the hearing clerk shall serve a copy of the document upon Respondent and the Office of the General Counsel of the Agency, Respondent shall, by counsel, thereupon file with the hearing clerk a copy of the appropriate notice of intention to cancel, the notice of intention to change the classification or the registration refusal order. Appearances, Intervention, and Consolidation § 164.30 Appearances. Representatives. § 164.31 Intervention. (a) Motion. (b) When filed. (c) Disposition. (d) Amicus curiae. [38 FR 19371, July 20, 1973, as amended at 57 FR 5342, Feb. 13, 1992] § 164.32 Consolidation. The Chief Administrative Law Judge, by motion or sua sponte, may consolidate two or more proceedings whenever it appears that this will expedite or simplify consideration of the issues. Consolidation shall not affect the right of any party to raise issues that could have been raised if consolidation had not occurred. At the conclusion of proceedings consolidated under this section, the Administrative Law Judge shall issue one decision under § 164.90 unless one or more of the consolidated proceedings have been dismissed pursuant to § 164.91. Administrative Law Judge § 164.40 Qualifications and duties of Administrative Law Judge. (a) Qualifications. (b) Disqualification of the Administrative Law Judge. (2) Withdrawal sua sponte. The Administrative Law Judge may at any time withdraw from any proceedings in which he deems himself disqualified for any reason. (c) Conduct. (d) Power. (e) Absence or change of the Administrative Law Judge. [38 FR 19371, July 20, 1973, as amended at 38 FR 34117, Dec. 11, 1973; 57 FR 5342, Feb. 13, 1992] Prehearing Procedures and Discovery § 164.50 Prehearing conference and primary discovery. (a) Purpose of the prehearing conference. (1) The simplification of issues including listing of specific uses to be contested; (2) The necessity or desirability of amendments to the objections or statement of issues, or any document filed in response thereto; (3) The possibility of obtaining stipulations of fact and documents which will avoid unnecessary delay; (4) Matters of which official notice may be taken; (5) The limitation of the number of expert and other witnesses; (6) Procedure at the hearing except as so provided in § 164.80(a); (7) The use of verified written statements in lieu of oral direct testimony; (8) The intent of any party to request a scientific advisory committee as defined in § 164.2(f); (9) The issuance of subpoenas and subpoenas duces tecum for discovery and hearing purposes; (10) A setting of a time and place for the public hearing, after giving careful consideration to the convenience of all the parties, the witnesses, the public interest and the necessity for notice in the Federal Register (11) Any other matter that may expedite the hearing or aid in the disposition of the proceeding. (b) Primary discovery Exchange of witness lists and documents (c) Record of the prehearing conference. (d) Unavailability of a prehearing conference. (e) Submission of questions to an advisory committee General. (2) Preparation of questions. (3) Reference and report. (4) Request and submission subsequent to prehearing conference. [38 FR 19371, July 20, 1973, as amended at 39 FR 11884, Apr. 1, 1974] § 164.51 Other discovery. (a) General. supra, (b) Depositions upon oral questions. (c) Procedure. (2) If the Administrative Law Judge determines the motion should be granted, he shall issue an order and appropriate subpoenas, if necessary, for the taking of such discovery together with the conditions and terms thereof. Motions § 164.60 Motions. (a) General. (b) Response to motions. (c) Decision. [38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992] Subpoenas and Witness Fees § 164.70 Subpoenas. (a) The attendance of witnesses or the production of documentary evidence may, by subpoena, be required at any designated place of hearing or place of discovery. Subpoenas may be issued by the Administrative Law Judge sua sponte or upon a showing by an applicant that evidence sought for hearing is relevant and material to the issues involved in the hearing or that the sought discovery pursuant to § 164.51 meets the standards set forth therein. The Administrative Law Judge shall be guided by the principles of the Federal Rules of Civil Procedure in making any order for the protection of a witness or the content of the documents produced. (b) Motion for subpoena duces tecum. (c) Service of subpoenas. § 164.71 Fees of witnesses. Witnesses summoned before the Administrative Law Judge shall be paid the same fees and mileage that are paid witnesses in the courts of the United States, and persons whose depositions are taken, and the persons taking the same, shall be entitled to the same fees as are paid for like services in the courts of the United States. Fees shall be paid by the party at whose instance the witness appears or the deposition is taken. The Hearings § 164.80 Order of proceeding and burden of proof. (a) At the hearing, the proponent of cancellation or change in classification has the burden of going forward to present an affirmative case for the cancellation or change in classification of the registration. In the case of the denial of an application for registration, the applicant shall have the burden of going forward. In the case of a hearing called by the Administrator, the Respondent has the burden of going forward to present an affirmative case as to the statement of issues. The party having the burden of going forward shall have the opportunity to submit evidence on rebuttal. (b) On all issues arising in connection with the hearing, the ultimate burden of persuasion shall rest with the proponent of the registration. (c) If any party, other than Respondent, after being duly notified, fails to appear at the hearing, he shall be deemed to have authorized the Administrative Law Judge to dismiss the proceeding with or without prejudice, as the Administrative Law Judge may determine, unless a motion excusing the failure to appear has been made and granted. In the event that a party appears at the hearing and no representative of the Agency appears, the Administrative Law Judge shall proceed ex parte Provided, § 164.81 Evidence. (a) General. (b) Report of a committee of the National Academy of Sciences. (c) Objections. (d) Exhibits. (e) Official Notice. (f) Offer of proof. (g) Verified statements. [38 FR 19371, July 20, 1973, as amended at 40 FR 25815, June 19, 1975; 57 FR 5343, Feb. 13, 1992] § 164.82 Transcripts. (a) Filing and certification. (b) [Reserved] Initial or Accelerated Decision § 164.90 Initial decision. (a) Proposed findings of fact, conclusions, and order. (b) Initial decision. [38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992] § 164.91 Accelerated decision. (a) General. (1) Untimely or insufficient objections filed pursuant to § 164.20; (2) Failure to comply with discovery orders; (3) Failure to comply with prehearing orders; (4) Failure to appear or to proceed at prehearing conferences; (5) Failure to appear at the hearing; (6) Failure to state a claim upon which relief can be granted, or direct or collateral estoppel. (7) Theat there is no genuine issue of any material fact and that the respondent is entitled to judgment as a matter of law; or (8) Such other and further reasons as are just. (b) Effect. Appeals § 164.100 Appeals from or review of interlocutory orders or rulings. Except as provided herein, appeals as a matter of right shall lie to the Environmental Appeals Board only from an initial or accelerated decision of the Administrative Law Judge. Appeals from other orders or rulings shall, except as provided in this section, lie only if the Administrative Law Judge certifies such orders or rulings for appeal, or otherwise as provided. The Administrative Law Judge may certify an order or ruling for appeal to the Environmental Appeals Board when: (a) The order or ruling involves an important question of law or policy about which there is substantial ground for difference of opinion; and (b) either (1) an immediate appeal from the order and ruling will materially advance the ultimate termination of the proceeding or (2) review after the final judgment is issued will be inadequate or ineffective. The Administrative Law Judge shall certify orders or rulings for appeal only upon the request of a party. If the Environmental Appeals Board determines that certification was improvidently granted, or takes no action within thirty (30) days of the certification, the appeal shall be deemed dismissed. When an order or ruling is not certified by the Administrative Law Judge, it shall be reviewed by the Environmental Appeals Board only upon appeal from the initial or accelerated decision except when the Environmental Appeals Board determines, upon request of a party and in exceptional circumstances, that delaying review would be deleterious to vital public or private interests. Except in extraordinary circumstances proceedings will not be stayed pending an interlocutory appeal; where a stay is granted, a stay of more than 30 days must be approved by the Environmental Appeals Board. Ordinarily, the interlocutory appeal will be decided on the basis of the submission made to the Administrative Law Judge, but the Environmental Appeals Board may allow further briefs and oral argument. [57 FR 5343, Feb. 13, 1992] § 164.101 Appeals from or review of initial decisions. (a) Exceptions and request for oral argument. (2) Within 7 days of the service of exceptions, and of a brief under paragraph (a)(1) of this section, any other party or amicus curiae may file and serve a brief responding to exceptions or arguments raised by any other party. Such brief shall include references to the relevant portions of the record. Such brief shall not, however, raise additional exceptions. (3) Five copies of all material filed under this section shall be filed with the hearing clerk. (b) Review by Administrator when no exceptions are filed. (c) Argument before the Environmental Appeals Board. (2) If the Environmental Appeals Board determines that additional exceptions should be argued, counsel for the parties shall be given reasonable written notice of such determination so as to permit preparation of adequate argument on all of the exceptions to be argued. [38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992] § 164.102 Appeals from accelerated decisions. (a) Within 20 days after filing of an accelerated decision by the Administrative Law Judge, any party may file exceptions and a supporting brief with the hearing clerk, stating with particularity the grounds upon which he asserts that the decision is incorrect. The party shall include in its brief page references to the relevant portions of the record, if applicable. (b) Within 7 days of the service of exceptions and brief under paragraph (a) of this section, any other party or amicus curiae may file and serve a brief responding thereto, with appropriate page references to the relevant portions of the record, if applicable. (c) Ordinarily, the appeal from an accelerated decision will be decided on the basis of the submission of briefs, but the Environmental Appeals Board may allow additional briefs and oral argument. [38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992] § 164.103 Final decision or order on appeal or review. Within 90 days after the close of the hearing or within 90 days from the filing of an accelerated decision, unless otherwise stipulated by the parties, the Environmental Appeals Board shall, on appeal or review from an initial or accelerated order of the Administrative Law Judge, issue its final decision and order, including its rulings on any exceptions filed by the parties; such final order may accept or reject all or part of the initial or accelerated decision of the Administrative Law Judge even if acceptable to the parties. [57 FR 5343, Feb. 13, 1992] § 164.110 Motion for reopening hearings; for rehearing; for reargument of any proceeding; or for reconsideration of order. (a) Filing; service. (b) Motion to reopen hearings. (c) Motions to rehear or reargue proceedings, or to reconsider final orders. [38 FR 19371, July 20, 1973, as amended at 57 FR 5343, Feb. 13, 1992] § 164.111 Procedure for disposition of motions. Within 7 days following the service of any motion provided for in § 164.110, any other party to the proceeding may file with the hearing clerk an answer thereto. As soon as practicable thereafter, the Environmental Appeals Board shall announce its decision whether to grant or to deny the motion. Unless the Environmental Appeals Board shall determine otherwise, operation of the order shall not be stayed pending the decision to grant or to deny the motion. In the event that any such motion is granted by the Environmental Appeals Board, the applicable rules of practice, as set out elsewhere herein, shall be followed. [38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992] Subpart C—General Rules of Practice for Expedited Hearings § 164.120 Notification. (a) Whenever the Administrator determines that action is necessary to prevent an imminent hazard during the time required for cancellation or change in classification proceedings, but that the hazard does not constitute an emergency, he shall notify the registrant of his intention to suspend registration of the pesticide at issue. (b) Such notice shall include findings pertaining to the question of imminent hazard and shall either be personally served on the registrant or be sent to the registrant by registered or certified mail, return receipt requested, and filed with the hearing clerk. § 164.121 Expedited hearing. (a) Request. (2) A request for an expedited hearing is timely if made in writing or by telegram and filed with the office of the hearing clerk within 5 days of the registrant's receipt of the notice of intention to suspend. (3) At the time of filing a request for an expedited hearing, the registrant shall also file a document setting forth objections to the Administrator's notice of intention to suspend and its findings pertaining to the question of imminent hazard. Such objections shall conform to the requirements of § 164.21. (b) Presiding officer. (2) The presiding officer shall not have the authority to make an initial decision on the merits but shall make a recommended decision only. (c) The issue. (d) Time of hearing. Federal Register (e) Intervention. (1) Leave to intervene will be granted only if the motion to intervene meets the standards of § 164.31 and, in addition, indicates that the movant would raise matters or introduce evidence pertinent to the issue of imminent hazard which would substantially assist in its resolution. (2) A movant denied permission to intervene under this section but who otherwise meets the standards of § 164.31 and who is adversely affected may file proposed findings and conclusions and briefs in support thereof pursuant to paragraph (j) of this section. Any person filing under this subsection shall be deemed to have been a party to the proceeding, for all purposes of its further review. (3) When an “emergency order” is issued pursuant to § 164.123, no person other than the respondent and the registrant shall participate in the hearing except that any person adversely affected may file proposed findings and conclusions and briefs in support thereof pursuant to paragraph (j) of this section. Any person filing under this subsection shall be deemed to have been a party to the proceeding for all purposes of its further review. (f) Appearances and consolidation. (g) Order of proceeding and burden of proof. (h) Evidence. (i) Transcripts. (j) Proposed findings or conclusions; recommended decision. (2) Within 8 days of the conclusion of the presentation of evidence, the Presiding Officer shall submit to the parties his proposed recommended findings and conclusions and a statement of the reasons on which they are based. (3) Within 10 days of the conclusion of the presentation of evidence the Presiding Officer shall submit to the Environmental Appeals Board his recommended findings and conclusions, together with the record. (4) Within 12 days of the conclusion of the presentation of evidence the parties shall submit to the Environmental Appeals Board their objections to the Presiding Officer's recommended findings and conclusions and written briefs in support thereof. [38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992] § 164.122 Final order and order of suspension. (a) Final order. (b) Order of suspension. [38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992] § 164.123 Emergency order. (a) Whenever the Environmental Appeals Board determines that an emergency exists that does not permit him to hold a hearing before suspension, the Environmental Appeals Board may issue a suspension order in advance of notification to the registrant. (b) The Environmental Appeals Board shall immediately notify the registrant of the suspension order. The registrant may then request a hearing in accordance with §§ 164.121 and 164.122, but the suspension order shall remain in effect during the hearing pending the issuance of a final order on suspension. [38 FR 19371, July 20, 1973, as amended at 57 FR 5344, Feb. 13, 1992] Subpart D—Rules of Practice for Applications Under Sections 3 and 18 To Modify Previous Cancellation or Suspension Orders Authority: Sec. 25(a) and 6 of the Federal Insecticide, Fungicide, and Rodenticide Act, as amended by the Federal Environmental Pesticide Control Act of 1972 (86 Stat. 997). Source: 40 FR 12265, Mar. 18, 1975, unless otherwise noted. § 164.130 General. EPA has determined that any application under section 3 or section 18 of the Act to allow use of a pesticide at a site and on a pest for which registration has been finally cancelled or suspended by the Administrator constitutes a petition for reconsideration of such order. Because of the extensive notice and hearing opportunities mandated by FIFRA and the Administrative Procedures Act before a final cancellation or suspension order may be issued, EPA has determined that such orders may not be reversed or modified without affording interested parties—who may in fact have participated in lengthy cancellation proceedings—similar notice and hearing opportunities. The procedures set forth in this subpart D shall govern all such applications. § 164.131 Review by Administrator. (a) The Administrator will review applications subject to this subpart D and supporting data submitted by the applicant to determine whether reconsideration of the Administrator's prior cancellation or suspension order is warranted. The Administrator shall determine that such reconsideration is warranted when he finds that: (1) The applicant has presented substantial new evidence which may materially affect the prior cancellation or suspension order and which was not available to the Administrator at the time he made his final cancellation or suspension determination and (2) such evidence could not, through the exercise of due diligence, have been discovered by the parties to the cancellation or suspension proceeding prior to the issuance of the final order. (b) If after review of the application and other supporting data submitted by the applicant, the Administrator determines, in accordance with paragraph (a) of this section, that reconsideration of his prior order is not warranted, then the application will be denied without requirement for an administrative hearing. The Administrator shall publish notice in the Federal Register (c) If after review of the application and other supporting data submitted by the applicant, the Administrator determines, in accordance with paragraph (a) of this section, that reconsideration of his prior order is warranted, he will then publish notice in the Federal Register § 164.132 Procedures governing hearing. (a) The burden of proof in the hearing convened pursuant to § 164.131 shall be on the applicant and he shall proceed first. The issues in the hearing shall be whether: (1) Substantial new evidence exists and (2) such substantial new evidence requires reversal or modification of the existing cancellation or suspension order. The determination of these issues shall be made taking into account the human and environmental risks found by the Administrator in his cancellation or suspension determination and the cumulative effect of all past and present uses, including the requested use, and uses which may reasonably be anticipated to occur in the future as a result of granting the requested reversal or modification. The granting of a particular petition for use may not in itself pose a significant risk to man or the environment, but the cumulative impact of each additional use of the cancelled or suspended pesticide may re-establish, or serve to maintain, the significant risks previously found by the Administrator. (b) The presiding officer shall make recommendations, including findings of fact and conclusions and to the extent feasible, as determined by the presiding officer, the procedures at the hearing shall follow the Rules of Practice, set forth in subparts A and B of this part 164. § 164.133 Emergency waiver of hearing. (a) In the case of an application subject to this subpart D which is filed under section 18 of FIFRA, and regulations thereunder, and for which a hearing is required pursuant to § 164.131, the Administrator may dispense with the requirement of convening such a hearing in any case in which he determines: (1) That the application presents a situation involving need to use the pesticide to prevent an unacceptable risk: (i) To human health, or (ii) to fish or wildlife populations when such use would not pose a human health hazard; and (2) That there is no other feasible solution to such risk; and (3) That the time available to avert the risk to human health or fish and wildlife is insufficient to permit convening a hearing as required by § 164.131; and (4) That the public interest requires the granting of the requested use as soon as possible. (b) Notice of any determination made by the Administrator pursuant to paragraph (a) of this section shall be published in the Federal Register

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