Part 164 - Rules of practice governing hearings, under the federal insecticide, fungicide, and rodenticide act, arising from refusals to register, cancellations of registrati

§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 means the Federal Insecticide, Fungicide, and Rodenticide Act, as amended (86 Stat. 973) and other legislation supplementary thereto and amendatory thereof.

(b) The term Administrative Law Judge means an Administrative Law Judge appointed pursuant to 5 U.S.C. 3105 (see also 5 CFR part 930, as amended), and such term is synonymous with the term “Hearing Examiner” as used in the Act or in the United States Code.

(c) The term Administrator means the Administrator of the United States Environmental Protection Agency.

(d) The term Agency, unless otherwise specified, means the United States Environmental Protection Agency.

(e) The term Applicant means any person who has made application to have a pesticide registered or classified pursuant to the provisions of the Act.

(f) The term Committee means a group of qualified scientists designated by the National Academy of Sciences according to agreement under the Act to submit an independent report to the Administrative Law Judge on questions of scientific fact referred from a hearing under subpart B of this part.

(g) Environmental Appeals Board shall mean the Board within the Agency described in §1.25 of this title. The Administrator delegates authority to the Environmental Appeals Board to issue final decisions in appeals filed under subparts B and C of this part. An appeal directed to the Administrator, rather than to the Environmental Appeals Board, will not be considered. This delegation does not preclude the Environmental Appeals Board from referring an appeal or a motion under subparts B and C to the Administrator when the Environmental Appeals Board, in its discretion, deems it appropriate to do so. When an appeal or motion is referred to the Administrator, all of the parties shall be so notified and the rules in subparts B and C referring to the Environmental Appeals Board shall be interpreted as referring to the Administrator.

(h) The term Expedited Hearing means a hearing commenced as the result of the issuance of a notice of intention to suspend or the suspension of a registration of a pesticide by an emergency order, and is limited to a consideration as to whether a pesticide presents an imminent hazard which justifies such suspension.

(i) The term Hearing means a public hearing which is conducted pursuant to the provisions of chapter 5, subchapter II of title 5 of the United States Code and the regulations of this part.

(j) The term Hearing Clerk means the Hearing Clerk, Environmental Protection Agency, Washington, DC 20460.

(k) The term Initial Decision means the decision of the Administrative Law Judge supported by findings of fact and conclusions regarding all material issues of law, fact, or discretion, as well as reasons therefor. Such decision shall become the final decision and order of the Administrator without further proceedings unless an appeal therefrom is taken or the Administrator orders review thereof as herein provided.

(l) The term Judicial Officer means an officer or employee of the Agency designated as a judicial officer, pursuant to these rules, who shall meet the qualifications and perform functions as herein provided.

(1) Office. There may be designated for the Agency one or more judicial officers, one of whom may be Chief Judicial Officer. As work requires, there may be a judicial officer designated to act for the purpose of a particular case. All prior designations of judicial officer shall stay in force until further notice.

(2) Qualification. A judicial officer shall be a permanent or temporary employee or officer of the Agency who may perform other duties for the Agency. Such judicial officer shall not be employed by the Office of Chemical Safety and Pollution Prevention or have any connection with the preparation or presentation of evidence for a hearing.

(3) Functions. The Administrator may delegate any or part of his authority to act in a given case under subparts B and C of this part to a judicial officer. The Administrator can separately delegate his authority to rule on interlocutory orders and motions, and may also delegate his authority to make findings of fact and draw conclusions of law in a particular proceeding, providing that this delegation shall not preclude the Judicial Officer from referring any motion or case to the Administrator when the Judicial Officer determines such referral to be appropriate. The Administrator, in deciding a case himself, may consult with and assign the preliminary drafting of conclusions of law and findings of fact to any judicial officer.

(m) The term Party means any person, group, organization, or Federal agency or department that participates in a hearing.

(n) The term Person includes any individual, partnership, association, corporation, and any organized group of persons, whether incorporated or not.

(o) The term Petitioner means any person adversely affected by a notice of the Administrator who requests a public hearing.

(p) The term Presiding Officer means any person designated by the Administrator to conduct an expedited hearing.

(q) The term Recommended Decision means the recommended findings and conclusions of the Presiding Officer in an expedited hearing.

(r) The term Registrant means any person who has registered a pesticide pursuant to the provisions of the Act.

(s) The term Respondent means the Assistant Administrator of the Office of Chemical Safety and Pollution Prevention.

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. All orders, decisions, or other signed documents required by the rules in this part, whether issued by the Environmental Appeals Board or the Presiding Officer shall be made available to the public.

(b) Establishment of an Agency repository. In addition, all transcripts and docket entries shall become part of the official docket and shall be retained by the hearing clerk. At least two copies of all final orders, decisions and a notification of any appeals taken therefrom shall be retained by the hearing clerk and filed chronologically and shall be periodically bound and indexed. All the above documents shall be made available to the public for reasonable inspections during Agency business hours.

(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 and sealed to all but the parties.

(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. In computing any period of time prescribed or allowed by these rules, except as otherwise provided, the day of the act, event, or default from which the designated period of time begins to run shall not be included. Saturdays, Sundays, and legal holidays shall be included in computing the time allowed for the filing of any document or paper, except that when such time expires on a Saturday, Sunday, or legal holiday, such period shall be extended to include the next following business day.

(b) Enlargement. When by these rules or by order of the Administrative Law Judge, the Presiding Officer, or the Environmental Appeals Board, an act is required or allowed to be done at or within a specified time, the Administrative Law Judge (before his initial decision is filed), or the Presiding Officer (before his recommended decision is filed), or the Environmental Appeals Board (after the Administrative Law Judge's initial decision or the presiding officer's recommended decision is filed), for cause shown may at any time in their discretion: with or without motion or notice, order the period enlarged if request therefor, which may be made ex parte, is made before the expiration of the period originally prescribed or as extended by a previous order; or on motion made after the expiration of the specified period, permit the act to be done where the failure to act was the result of excusable neglect. In this connection, consideration shall be given to the fact that, under the provisions of the act, the Administrator must issue his order not later than 90 days after the completion of the hearing, unless all parties agree by stipulation to extend this period of time pursuant to §164.103.

(c) Additional time after service by mail. A prescribed period of time within which a party is required or permitted to do an act shall be computed from the time of service, except that when the service is made by mail, 3 days shall be added to the prescribed period. Such addition for service by mail shall not apply in the case of filing initial requests for hearings or responding to a notice of intent to hold a hearing, in which cases statutory filing times will run from the date of the return receipt pursuant to §164.8.

[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 the merits of the proceeding with any party or with any person who has been connected with the preparation or presentation of the proceeding as an advocate, or in an investigative or expert capacity, or with any representative of such person, Provided, That the Environmental Appeals Board, the Presiding Officer, or the Administrative Law Judge may discuss the merits of the case with any such person if all parties to the proceeding, or their representatives, have been given reasonable notice and opportunity to be present. Any memorandum or other communication addressed to the Administrator, the Environmental Appeals Board, the Presiding Officer, or the Administrative Law Judge during the pendency of the proceeding, and relating to the merits thereof, by or on behalf of any party, shall be regarded as an argument made in the proceeding. The Administrator, the Environmental Appeals Board, the Presiding Officer, or the Administrative Law Judge shall cause any such communication to be filed with the hearing clerk and served upon all other parties to the proceeding who will be given the opportunity to file an answer thereto.

[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 by the Administrator. The Administrative Law Judge shall cause to be published in the Federal Register by appropriate announcement, a notice of the filing of any objections, pursuant to §164.20(b) or responses pursuant to §164.24, and a notice of the public hearing as provided by §164.80 et seq. Said notice of public hearing shall designate the place where the hearing will be held and specify the time when the hearing will commence. The hearing shall convene at the place and time announced in the notice, unless amended by subsequent notice published in the Federal Register, but thereafter it may be moved to a different place and may be continued from day to day or recessed to a later day without other notice than announcement thereof at the hearing.

§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.(1) An expedited hearing shall be held whenever the Administrator has received from the registrant a timely request for such hearing in response to the Administrator's notice of intention to suspend.

(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.(1) An expedited hearing shall be conducted by a presiding officer appointed by the Administrator, and such officer need not be an Administrative Law Judge.

(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. The expedited hearing shall address only the issue of whether an imminent hazard exists.

(d) Time of hearing. The hearing shall commence within 5 days after the filing of the request with the office of the hearing clerk unless the registrant and respondent agree that it shall commence at a later time. As soon as possible, the presiding officer shall publish in the Federal Register notice of such hearing.

(e) Intervention. Any person adversely affected by the Administrator's notice may move to intervene within 5 days after the receipt by the registrant of said notice or at any time prior to the conclusion of the presentation of the evidence, upon good cause found, except

(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. The provisions of §§164.30 and 164.32 apply to an expedited hearing insofar as may be practicable.

(g) Order of proceeding and burden of proof. At the hearing, the proponent of suspension shall have the burden of going forward to present an affirmative case for the suspension. However, the ultimate burden of persuasion shall rest with the proponent of the registration.

(h) Evidence. The provisions of §164.81, where applicable, apply to an expedited hearing.

(i) Transcripts. The presiding officer shall make provision for daily transcripts and otherwise comply with the provisions of §164.82.

(j) Proposed findings or conclusions; recommended decision.(1) Within 4 days of the conclusion of the presentation of evidence, the parties may propose findings and conclusions to the Presiding Officer. Such proposed findings and conclusions shall be accompanied by a brief with supporting reasons.

(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. Within 7 days of receipt of the record and of the Presiding Officer's recommended findings and conclusions, the Environmental Appeals Board shall issue a final decision and order. Such final order may accept or reject in whole or in part the recommendations of the Presiding Officer.

(b) Order of suspension. No final order of suspension shall be issued unless the Environmental Appeals Board has issued or at the same time issues a notice of its intention to cancel the registration or change the classification of the pesticide. Such notice shall be given as provided in §164.8.

[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]

§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 of the denial briefly describing the basis for his determination as soon as practicable. Such denial shall constitute final agency action.

(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 setting forth his determination and briefly describing the basis for the determination. Such notice shall announce that a formal public hearing will be held in accordance with 5 U.S.C. section 554. The notice shall specify: (1) The date on which the hearing will begin and end, (2) the issues of fact and law to be adjudicated at the hearing, (3) the date on which the presiding officer shall submit his recommendations, including findings of fact and conclusions, to the Administrator, and (4) the date on which a decision by the Administrator is anticipated.

§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 as soon as practicable after granting the requested use and shall set forth the basis for the Administrator's determination.