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164.37

164.38

164.39

164.40

164.41

164.42

Exceptions, objections, request for
oral argument.

Argument before the Administrator.
Final order.

Ex parte discussion of proceeding.
Application for reopening hearings;
for rehearing; or reargument of
proceeding; or for reconsideration
of order.

Procedure for disposition of petitions. 164.43 Filing and service.

164.44 Computation and extensions of time.

AUTHORITY: The provisions of this Part 164 issued under secs. 4, 6, 61 Stat. 167-168, as amended; 7 U.S.C. 135b, 135d.

Subpart A-General

SOURCE: 36 FR 22535, Nov. 25, 1971, unless otherwise noted.

§ 164.1 Meaning of words.

As used in this part, words in the singular form shall be deemed to import the plural, and vice-versa, as the case may require.

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For the purposes of this part, the following terms shall be construed, respectively, to mean:

(a) The term "Act" means the Federal Insecticide, Fungicide, and Rodenticide Act (61 Stat. 163, et seq. as amended, 7 U.S.C. 135-135k).

(b) The term "person" includes any individual, partnership, association, corporation, or any organized group of persons, whether incorporated or not.

(c) The term "Administrator" means the Administrator of the Environmental Protection Agency of the United States, or any officer or employee of the Environmental Protection Agency to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead, including the Judicial Officer of the Environmental Protection Agency.

(d) The term "Hearing Clerk" means the Hearing Clerk, Environmental Protection Agency, Washington, D.C. 20250.

(e) The term "Examiner" means an examiner in the Office of the Hearing Examiners, Environmental Protection Agency.

(f) The term "Examiner's Report" means the report made by the Examiner to the Administrator with respect to proposed:

(1) Findings of fact and conclusions regarding all material issues of fact, law or discretion, as well as the reasons or basis therefor, and

(2) Order.

(g) [Reserved]

(h) The term "Director" means the Director, Pesticides Regulation Division, Environmental Protection Agency, or any official or employee of the Environmental Protection Agency to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead.

(i) The term "Division" means the Pesticides Regulation Division, Environmental Protection Agency.

(j) The term "applicant" means any person who has made application to have an economic poison1 registered pursuant to the provisions of the Act.

(k) The term "registrant" means any person who has registered an economic poison1 pursuant to the provisions of the Act.

(1) The term "petitioner" means any person who has been notified that his application for registration of an economic poison' has been refused or any person who has received a notice of cancellation or suspension of the registration of an economic poison' under the Act, and who has filed a petition requesting that the matter be referred to an advisory committee.

(m) The term "advisory committee" means a group of qualified experts designated to submit an independent report to the Administrator regarding the registration of an economic poison.1

(n) The term "hearing" means any action arising under the Act, in which it is required by law that relevant and material evidence be received at a public hearing.

(o) The term "final order" includes the Administrator's findings, conclusions, order and rulings on motions, exceptions, statements of objections and proposed findings, conclusions and orders submitted by parties and not theretofore ruled upon.

1 See definition of "economic poison" and related terms contained in section 2 of the Act (7 U.S.C. 135b) and § 162.2 of the regulations for the enforcement of the Act (7 CFR 162.2).

$164.3 Scope and applicability of this part.

The provisions of Subpart B of this part shall be applicable to the appointment, compensation, and proceedings of an advisory committee; and the provisions of Subpart C of this part shall govern hearings conducted pursuant to the provisions of the Act.

§ 164.4 Submission of a determination respecting an economic poison to an advisory committee, and institution of a hearing regarding the application for registration or cancellation or suspension of an economic poison under the Act.

(a) Applications for registration of an economic poison under the Act. Whenever the Director shall determine, in connection with an application for registration of an economic poison under the Act, that it does not appear that the article is such as to warrant the proposed claims for it or if the article and its labeling and other material required to be submitted do not comply with the provisions of the Act, the Director shall notify the applicant of the manner in which the article, labeling, or other material required to be submitted fail to comply with the Act and the applicant shall have an opportunity to make the necessary corrections. If the applicant does not make the corrections, the Director will refuse to register the article: Provided, however, That an applicant may, within 30 days after service of notice of refusal to register and the reasons therefor:

(1) File a petition with the Hearing Clerk requesting that the matter be referred to an advisory committee, or

(2) File objections with the Hearing Clerk to the determination of the Director and request a public hearing respecting the matter.

(b) Cancellation of the registration of an economic poison under the Act. The Director may cancel the registration of an economic poison whenever it does not appear that the article or its labeling or other material required to be submitted complies with the provisions of the Act. Whenever the Director determines that a registration of an economic poison should be canceled, he will notify the registrant of his action and state the reasons therefor. A cancellation of registration shall be effective 30 days after service of the cancellation notice on the registrant, unless within such time the registrant:

(1) Makes the necessary corrections; (2) Files a petition with the Hearing Clerk requesting that the matter be referred to an advisory committee; or (3) Files objections with the Hearing Clerk and requests a public hearing.

(c) Suspension of the registration of an economic poison under the Act. Whenever the Director finds that such action is necessary to prevent an imminent hazard to the public, he may, by order, suspend the registration of the economic poison immediately. In such event, the Director will give the registrant notice of the action and the registrant shall have the opportunity to have the matter submitted to an advisory committee and shall have the opportunity for an expedited hearing regarding the matter.

(d) Procedure available if there is an adverse order after referral to an advisory committee. If a matter regarding the registration of an economic poison has been referred to an advisory committee and thereafter the Administrator makes a determination and issues an order that is adverse to the applicant or registrant, the applicant or the registrant may, within 60 days from the date of the order of the Administrator, file objections thereto with the Hearing Clerk and request a public hearing regarding the matter.

(e) Referral to an advisory committee at the request of the Administrator. The Administrator may, on his own initative and when in his opinion it is desirable to have an independent evaluation respecting the merits of the registration of any economic poison, refer the matter to an advisory committee. In such event, the Administrator shall give the applicant or the registrant notice of the submission of the matter to the advisory committee. Subpart B-Rules Governing the Ap

pointment, Compensation, and Proceedings of an Advisory Committee SOURCE: 36 FR 22535, Nov. 25, 1971, unless otherwise noted.

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a land-grant college, willing to serve on the advisory committee. All such experts shall have had sufficient training and experience in toxicology, pharmacology, bacteriology, chemistry, entomology, plant pathology and physiology, human pathology and physiology, or other appropriate science to evaluate the safety or efficacy of economic poisons. The Administrator will request the National Academy of Sciences, when it furnishes the names of such experts, to supply a biographical sketch showing the background of their experience and their connection, if any, with academic and commercial institutions.

(b) Number of experts. The Administrator shall designate the number and names of experts to serve on the advisory committee, and each such committee shall have at least one expert who is a representative from a land-grant college. The Administrator shall appoint one member of the committee as chairman, and the chairman shall be the spokesman of the committee for receiving and forwarding reports and other functions of the committee.

(c) Compensation for experts. The Administrator shall appoint the experts so selected and fix their compensation at not to exceed the maximum permitted by other authority per day for each day or part thereof spent in committee meetings, plus necessary traveling and subsistence expenses while the experts are serving away from their places of residence. Subsistence expenses shall not exceed the maximum per diem permitted by this Department.

§ 164.11 Procedure for advisory com

mittee.

(a) Submission of information to advisory committee. The Administrator shall submit to the chairman of the committee the petition and such other relevant information as he may have available with respect to registration of the product. When the Administrator submits a matter to an advisory committee he shall inform the applicant or the registrant and shall furnish him with copies of the material that is furnished to the committee. The chairman shall acknowledge receipt of the information and readiness of the committee to act. A copy of this acknowledgment shall be forwarded to the applicant or registrant by the chairman of the committee.

(b) Advisory committee meetings. A secretariat to advisory committees will

be established by the Administrator. The secretariat shall furnish members of the committee with copies of the petition and any data received by the chairman. If the chairman of the committee believes that a meeting of the committee is necessary before making a recommendation, he shall so advise the Administrator and the petitioner. Such meeting shall be held in Washington, D.C., or such other place as the Administrator may designate. The Administrator shall furnish a suitable meeting place for the committee. If a meeting is held, the secretariat shall keep the minutes and provide clerical assistance.

(c) Report of the advisory committee. As soon as practicable, but not later than 60 days after the date on which the information referred to in paragraph (a) of this section has been submitted to the committee (unless the time has been extended as provided in paragraph (d) of this section), the chairman shall certify to the Administrator the report of the committee, including any minority report. The report shall include a recommendation as to the registration of the article and a statement of the reasons or basis for the recommendation, together with copies of all relevant data or material considered by the committee, except that in the case of scientific literature readily available in scientific libraries, proper reference may be made to it instead of furnishing actual copies. The report of the advisory committee shall be available for inspection by any interested person after the Administrator's order with respect to registration of the product is issued.

(d) Extension of time for advisory committee report. If at any time within the 60-day period referred to in paragraph (c) of this section the chairman believes that the advisory committee needs more time, he shall so inform the Administrator in writing, in which case the Administrator may extend said time not to exceed 60 additional days. Notification of any such extension of time will be sent to the applicant or registrant by the Administrator.

(e) Assessment of costs of submission to an advisory committee. (1) In the event that an applicant or a registrant requests that a matter concerning the registration of an economic poison be referred to an advisory committee, the costs of such referral shall be borne by the applicant or the registrant unless the

committee shall recommend in favor of the applicant or the registrant.

(2) Costs of the advisory committee shall include compensation for experts as provided in § 164.10 (c) and the expenses of the secretariat, including the costs of duplicating petitions and other related material referred to the committee.

(3) An advance deposit shall be made in the amount of $2,500 to cover the costs. Further advance deposits of $2,500 each shall be made upon request of the Administrator when necessary to prevent arrears in the payment of such costs. Any deposits in excess of actual expenses will be refunded to the depositor.

(4) All deposits and fees required by the regulations in this part shall be paid by money order, bank draft, or certified check drawn to the order of the Environmental Protection Agency, Washington, D.C. 20250, whereupon after making appropriate record thereof they will be transmitted to the Treasurer of the United States, for deposit to the proper account.

(5) The Administrator may waive or refund such fees in whole or in part when in his judgment such action will be warranted and equitable under the particular circumstances and promote the public interest.

(6) Any person who believes that payment of these fees will work a hardship on him may petition the Administrator to waive or refund the fees.

(f) Consultation with advisory committee. The applicant or registrant and representatives of the Environmental Protection Agency shall have the right to consult with the advisory committee. Such persons shall notify the chairman of a desire to consult with the committee and, if practicable, make appointments through him. The report of the advisory committee shall show the names of all persons, other than committee members, discussing the petition or referral with the committee or a committee member.

(g) Confidentiality of data. All data submitted to an advisory committee shall be considered confidential by such committee: Provided, That this provision shall not be construed as prohibiting the use of such data by the Committee in connection with its consultation with the applicant or registrant or representatives of the Environmental Protection Agency, and in connection with its report and recommendations to the Administrator.

(h) Order of the Administrator. The date of receipt of the advisory committee report and recommendations shall be the date for computing the time for the Administrator to act with respect to registration of the economic poison. Within 90 days of such date, the Administrator shall make his determination and issue an order, with findings of fact, with respect to the registration of the economic poison. The Administrator shall serve & copy of his order on the applicant or the registrant.

(i) National Academy of Sciences to designate committee member to testify. The National Academy of Sciences shall designate one of the committee members who will be available to appear and testify at the request of the Administrator, the applicant or registrant, or the Examiner, at a public hearing, if one occurs, with respect to the report and recommendations of the committee, and the Academy shall notify the Administrator of the name of such member: Provided, however, That this shall not preclude any other member of the committee from being requested to appear and testify at such hearing.

Subpart C-Rules of Practice
Governing Hearings

SOURCE: 37 FR 9478, May 11, 1972, unless otherwise noted. § 164.20

Docketing of request for

hearing.

Whenever a document setting forth objections and requesting a public hearing is filed with the hearing clerk, the matter shall be docketed and assigned and "I.F.&R." docket number: Provided, That if the matter has previously been assigned an "I.F.&R." number pursuant to § 164.10, it shall be assigned that same number. Notice of the filing of such objection shall be given to the public by appropriate announcement in the FEDERAL REGISTER.

§ 164.21 Contents of document setting forth objections.

(a) Concise statement required. Any document containing objections to an order of the Administrator refusing to register an economic poison or determining to cancel or suspend the registration of such a product, shall clearly and concisely set forth such objections and the basis for each objection, including relevant allegations of fact concerning the economic poison under consideration. The document shall indicate the

registration number of the economic poison involved.

(b) Amendments to objections. Objections may be amended at any time prior to the commencement of the public hearing by leave of the examiner or by written consent of all adverse parties. The examiner shall freely grant such leave when justice so requires. If the examiner determines that additional time is necessary in order to permit a party to prepare for matters raised by amendments to objections, the commencement of the hearing shall be delayed for an appropriate period.

§ 164.22 Filing copies of notification respecting registration.

After a copy of the document setting forth the objections and requesting a public hearing is served upon the Administrator, the Administrator shall file with the hearing clerk a copy of the notice of cancellation or suspension of the registration of such economic poison or the registration refusal order. § 164.23 Answer to objections.

The filing of an answer to objections is not required. If the examiner finds that the notice of cancellation or suspension or denial of registration does not sufficiently articulate the reasons for such action, he may require the Agency to file an answer. The answer shall be filed within 30 days of receipt of the examiner's order.

§ 164.24 Motions and requests.

(a) General. All motions and requests except those made orally during the course of a public hearing must be in writing and shall be filed with the hearing clerk. The examiner is authorized to rule upon all motions and requests filed or made prior to the filing of his report with the hearing clerk as hereinafter provided in § 164.36. The Administrator will rule upon all motions and requests filed after that time.

(b) Motions. All motions and requests concerning the sufficiency of the objections must be made within 30 days after service of the objections. All such motions and requests shall state with particularity the ground upon which the objection is alleged to be insufficient and shall state the nature of the relief requested.

(c) Answers to motions and requests. Within 10 days after service of any written motion or request filed pursuant to

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this subpart, or within such other time as may be fixed by the Administrator or examiner, an opposing party shall file an answer to the motion or request or shall be deemed to have no objection to the granting of the relief asked for in the motion or request. Unless specifically permitted by the Administrator or the examiner on motion made by a party, the movant shall have no right to respond to the answer to his motion.

(d) Certification of interlocutory issues to the Administrator. Except as provided herein, appeals shall lie to the Administrator only from a final judgment by the hearing examiner. Appeals from other rulings will, except as provided in this section, lie only if the examiner certifies such rulings for appeal. The examiner shall certify a ruling for appeal to the Administrator when: (1) The ruling involves an important question of law or policy about which there is substantial ground for difference of opinion; and (2) either an immediate appeal from the ruling will materially advance the ultimate termination of the proceeding or review after the final judgment is issued will be inadequate or ineffective. The examiner shall certify rulings for appeal only upon the request of a party. If the Administrator determines that certification was improvidently granted, or takes no action within 30 days of the certification, the appeal shall be deemed dismissed. When a ruling is not certified by the examiner, it shall be reviewed by the Administrator only upon appeal from the final judgment except when the Administrator determines, upon request of a party and in exceptional circumstances, that delaying review would be deleterious to vital public or private interests. Except under extraordinary circumstances, proceedings will not be stayed pending an interlocutory appeal; a stay of more than 30 days must be approved by the Administrator. Ordinarily, the interlocutory appeal will be decided on the basis of the submission made to the examiner, but the Administrator may allow further briefs and oral argument. § 164.25

Intervention.

(a) Pleading. Any person may file a petition for leave to intervene in a hearing conducted under this Subpart. A petition must set forth the grounds for the proposed intervention and the position and interest of the petitioner in the proceeding.

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