taken by the petitioner to submit the sample. If the sample is not submitted within 180 days after mailing date of the request, the petition will be considered withdrawn without prejudice.

(f) The date of receipt from the Administration of certification as to usefulness shall be the date used for computing the 90-day limit for the purposes of section 408(d) (2).

(g) Unless the petition is referred to an advisory committee, the Administrator shall publish in the FEDERAL REGISTER within 90 days after receipt of the certification of usefulness, a regulation establishing a tolerance for residues of the pesticide chemical or exempting such residues from the necessity of a tolerance, as provided in section 408(d) (2) of the act.

(Sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371)

§ 180.8 Withdrawal of petitions without prejudice.

In some cases the Pesticides Tolerance Division or an advisory committee to which the petition has been referred will notify the petitioner that the petition, while technically complete, is inadequate to justify the establishment of a tolerance or the tolerance requested by petitioner. This may be due to the fact that the data are not sufficiently clear or complete. In such cases, the petitioner may withdraw the petition pending its clarification or the obtaining of additional data. This withdrawal may be without prejudice to a future filing. Upon refiling, the time limitation will begin to run anew from the date of refiling or the date of receipt of certification from the Administrator, whichever is later. A deposit for fees as specified in § 180.33 (f) shall accompany the resubmission of the petition.

(Sec. 701, 52 Stat. 1055, as amended; 21 U.S.C. 371)

§ 180.9 Substantive amendments to petitions.

After a petition has been filed or referred to an advisory committee, the petitioner may submit additional information or data in support thereof, but in such cases the petition will be given a new filing date or a new initial date of consideration by the advisory committee, and the time limitation will begin to run anew. The additional data shall be accompanied by a deposit of fees as specified in § 180.33(g).

(a) If within the prescribed period a person filing a petition requests that the petition be referred to an advisory committee, he shall make such request in writing to the Administrator and forward with such request an advance deposit for fees prescribed by § 180.33 (i) (3).

(b) If further advance deposits are not made upon request of the Administrator, as provided for in § 180.33 (i) (3), the request for referral of the petition to an advisory committee shall be considered withdrawn, and a tolerance shall be established within 90 days of the date on which the Administrator requested the further advance deposit.

(c) In case the Administrator on his own initiative deems it necessary to refer a petition to an advisory committee, he shall, in writing, so inform the person filing the petition.

§ 180.11 Appointment of advisory committee.

(a) Whenever the referral of a petition or proposal to an advisory committee is requested or the Administrator otherwise deems such referral necessary, the Administrator will request the National Academy of Sciences, National Research Council, to select qualified experts, including at least one representative from land-grant colleges, willing to serve on the advisory committee. All such experts shall have had sufficient training and experience in biology, medicine, physiology, toxicology, pharmacology, veterinary medicine, or other appropriate science to evaluate the safety of pesticide chemicals. 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) Each advisory committee shall consist of not less than three experts. at least one of whom is a representative from a land-grant college. The Administrator may specify a larger number to serve. He 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) 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 and in traveling to and from committee meetings held outside the city of their residence, 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 other authority.

§ 180.12 Procedure for advisory committee.

(a) The Administrator shall submit to the chairman of the committee the petition for tolerances, together with certification by the Administrator and such other relevant, reliable information as may be available. When the Administrator submits a proposal to an advisory committee, he shall inform the petitioner and furnish him with copies of material other than the petition and certification that is furnished the committee. The chairman of the committee shall acknowledge receipt of the information and readiness of the committee to act. The date of receipt of such information shall be considered the beginning of the period allowed for consideration by the committee. Copy of this acknowledgment shall be forwarded to the petitioner by the chairman of the committee.

(b) A secretariat to advisory committees will be established by the Administrator. The secretariat shall furnish members of the committee with copies of the proposal or petition, certification from the Administrator, 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. Such meetings 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) As soon as practicable, but not later than 60 days after receipt of proposal or petition (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, and shall return the petition for tolerances and the certification. The report will include copies of all relevant 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 a tolerance or exemption resulting from the petition is published.

(d) If at any time within 60 days, the chairman believes that the advisory committee needs more time, he shall so inform the Administrator in writing, in which case he shall make the certification contemplated by section 408 (d) (3) of the act within the additional 30 days.

(e) The date of receipt of the committee report will be the date for computing time for the Administrator to act for the purposes of both sections 408 (d) (3) and (e).

(f) The chairman of the committee, after consultation with the committee members, will inform the National Academy of Sciences of the committee's opinion as to the member who may best represent the committe at a hearing, if

one occurs.

(g) More than one petition or proposal may be handled by a committee concurrently.

(h) Persons authorized under section 408 (h) to discuss proposals or petitions with the committee shall notify the chairman and if practicable make appointments through him. The report of the committee shall show the names of persons other than committee members discussing proposals or petitions with the committee. Except for discussions with authorized persons the committee shall not disclose data originating with a petitioner prior to publication of a regulation.

PROCEDURE FOR FILING OBJECTIONS AND HOLDING A PUBLIC HEARING

(b) A statement of objections shall not be accepted for filing if:

(1) It fails to establish that the objector is adversely affected by the regulation; or

(2) It does not specify with particularity the provisions of the regulation to which objection is taken; or

(3) It does not state reasonable grounds for each objection raised. Grounds which it is reasonable to conclude are capable of being established by reliable evidence at the hearing and which if proved would call for changing the provisions specified in the objections will be deemed reasonable grounds.

(c) If the statement of objections may not be filed, the Administrator shall inform the objector of the reasons.

(d) If objections to a regulation issued pursuant to a petition are filled by a person other than the petitioner, the Agency shall send a copy of the objections by certified mail, return receipt requested, to the petitioner at the address given in the petition. Petitioner shall have 2 weeks from the date of receipt of the objections to make written reply.

§ 180.14

Public hearing; notice.

If the objections and statements filed by any person, when they are considered with the record in the proceeding (including any reply to the objections that the petitioner may have filed) show that the person filing the objections is adversely affected and that the grounds stated in support of the objections are reasonable, the Administrator shall cause to be published in the FEDERAL REGISTER a notice reciting the objections and announcing a public hearing to receive evidence on them. The notice shall designate the place where the hearing will be held, specify the time within which appearances must be filed, and specify the time (not earlier than 30 days after the date of the notice) when the hearing will start. The hearing shall convene at the place and time announced in the notice 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 by the presiding officer at the hearing.

§ 180.15 Presiding officer.

The hearing shall be conducted by a presiding officer, who shall be a hearing examiner appointed as provided in the Administrative Procedure Act and desig

nated by the Administrator for conducting the hearing. Any such designation may be made or revoked by the Administrator at any time. Hearings shall be conducted in an informal but orderly manner in accordance with these regulations and the requirements of the Administrative Procedure Act. The presiding officer shall have the power to administer oaths and affirmations; to request the member of an advisory committee designated as provided by section 408 (d) (5) to testify with respect to the report and recommendations of the committee; to rule upon offers of proof and admissibility of evidence; to receive relevant evidence; to examine witnesses; to regulate the course of the hearing; to hold conferences for the simplification of the issues, and to dispose of procedural requests; but he shall not have power to decide any motion that involves final determination of the merits of the proceeding.

§ 180.16 Parties; burden of proof; ap

pearances.

At the hearing, the person whose objections raised the issues to be determined shall be, within the meaning of section 7(c) of the Administrative Procedure Act, the proponent of the order sought, and accordingly shall have the burden of proof. Any interested person shall be given an opportunity to appear at the hearing, either in person or by his authorized representative, and to be heard with respect to matters relevant to the issues raised by the objections. Any interested person who desires to be heard at the hearing in person or through a representative shall, within the time specified in the notice of hearing, file with the presiding officer a written notice of appearance setting forth his name, address, and employment. If such person desires to be heard through a representative, such person or such representative shall file with the presiding officer a written appearance setting forth the name, address, and employment of such person. Any person or representative shall state with particularity in the appearance his interest in the proceedings and shall set forth the specific provisions of the regulations concerning which objections have been made on which such person desires to be heard. The appearance shall also set forth with particularity the position to be taken concerning the objections on which he wishes to be heard. No person shall be

heard if he failed to file his appearance within the time prescribed in the absence of a clear showing of good cause why the appearance was not filled. All present at the hearing shall conform to all reasonable standards of orderly and ethical conduct.

§ 180.17 Prehearing and other conferences.

(a) The presiding officer, on his own motion, or on the motion of any party or his representative, may direct all parties or their representatives to appear at a specified time and place for a conference to consider:

(1) The simplification of the issues. (2) The possibility of obtaining stipulations, admissions of facts and documents.

(3) The limitation of the number of expert witnesses.

(4) The scheduling of witnesses to be called.

(5) The advance submission of all documentary evidence.

(6) Such other matters as may aid in the disposition of the proceeding.

The presiding officer shall make an order which recites the action taken at the conference, the agreements made by the parties or their representatives, and the schedule of witnesses, and which limits the issues for hearing to those not disposed of by admissions or agreements. Such order shall control the subsequent course of the proceeding unless modified for good cause by subsequent order.

(b) The presiding officer may also direct all parties and their representatives to appear at conferences at any time during the hearing with a view to simplification, clarification, or shortening of the hearing.

§ 180.18 Submission of documentary evidence in advance.

(a) All documentary evidence to be offered at the hearing shall be submitted to the presiding officer and to the parties sufficiently in advance of the offer of such documentary evidence for introduction into the record to permit study and preparation of cross-examination and rebuttal evidence.

(b) The presiding officer, after consultation with the parties at a conference called in accordance with § 180.17, shall make an order specifying the time at which documentary evidence shall be submitted. He shall also specify in his

order the time within which objection to the authenticity of such document must be made to comply with paragraph (d) of this section.

(c) Documentary evidence not submitted in advance in accordance with the requirements of paragraphs (a) and (b) of this section shall not be received in evidence in the absence of a clear showing that the offering party had good cause for his failure to produce the evidence sooner.

(d) The authenticity of all documents submitted in advance shall be deemed admitted unless written objection thereto is filed with the presiding officer upon notice to the other parties within the time specified by the presiding officer in accordance with paragraph (b) of this section, except that a party will be permitted to challenge such authenticity at a later time upon a clear showing of good cause for failure to have filled such written objection.

§ 180.19 Excerpts from documentary evidence.

When portions only of a document are to be relied upon, the offering party shall prepare the pertinent excerpts, adequately identified, and shall supply copies of such excerpts, together with a statement indicating the purpose for which such materials will be offered, to the presiding officer and to the other parties. Only the excerpts, so prepared and submitted, shall be received in the record. However, the whole of the original document should be made available for examination and for use by opposing counsel for purposes of cross-examination. § 180.20 Submission and receipt of evidence.

(a) Each witness shall, before proceeding to testify, be sworn or make affirmation.

(b) When necessary to prevent undue prolongation of the hearing, the presiding officer may limit the number of times any witness may testify, the repetitious examination and cross-examination of witnesses, or the amount of corroborative or cumulative evidence.

(c) The presiding officer shall admit only evidence which is relevant, material, and not unduly repetitious.

(d) Opinion evidence shall be admitted when the presiding officer is satisfied that the witness is properly qualified.

(e) The presiding officer shall file as exhibits the FEDERAL REGISTER promul

gating the regulation to which objections were taken and any report, recommendations, underlying data, and reasons that were certified to the Administrator by an advisory committee pursuant to section 408(d) (3). The report, recommendations, underlying data, and reasons shall be subject to section 7(c) of the Administrative Procedure Act. All documents constituting the record accumulated up to the start of the hearing shall be open for inspection by interested persons during office hours in the office of the hearing clerk of the Agency.

(f) The member of an advisory committee, if any, designated to testify, or any member requested to testify by the petitioner, the Agency, or the presiding officer, or who upon his own initiative requests to be heard, shall appear and testify with respect to the report, recommendations, underlying data, and reasons of the committee. The designated member shall receive per diem and travel and subsistence expenses when incurred, as though he were attending a meeting of the advisory committee.

(g) If any person objects to the admission or rejection of any evidence or to other limitation of the scope of any examination or cross-examination, he shall state briefly the grounds for such objection, and the transcript shall not include extended argument or debate thereon except as ordered by the presiding officer. A ruling of the presiding officer on any such objection shall be a part of the transcript, together with such offer of proof as has been made. § 180.21 Transcript of the testimony.

Testimony given at a hearing shall be reported verbatim. All written statements, charts, tabulations, and similar data offered in evidence at the hearing shall be marked for identification and, upon a showing satisfactory to the presiding officer of their authenticity, relevancy, and materiality, shall be received in evidence subject to the Administrative Procedure Act (sec. 7(c), 60 Stat. 238; 5 U.S.C. 1006(c)). Exhibits shall, if practicable, be submitted in quintuplicate. In case the required number of copies are not made available, the presiding officer shall exercise his discretion as to whether said exhibit shall be read in evidence or whether additional copies shall be required to be submitted within a time to be specified by the presiding officer. Where the testimony of a wit

ness refers to a statute or to a report or document, the presiding officer shall, after inquiry relating to the identification of such statute, report, or document, determine whether the same shall be produced at the hearing and physically be made a part of the evidence by reference. Where relevant and material matter offered in evidence is embraced in a report or document containing immaterial and irrelevant matter, such immaterial and irrelevant matter shall be excluded and shall be segregated insofar as practicable, subject to the direction of the presiding officer.

§ 180.22 Oral and written arguments.

(a) Unless the presiding officer issues an announcement at the hearing authorizing oral argument before him, it shall not be permitted.

(b) The presiding officer shall announce at the hearing a reasonable period within which interested persons may file written arguments based solely upon the evidence received at the hearing, citing the pages of the transcript of the testimony or properly identified exhibits where such evidence occurs.

§ 180.23 Indexing of record.

(a) Whenever it appears to the presiding officer that the record of hearing will be of such length that an index to the record will permit a more orderly presentation of the evidence and reduce delay, the presiding officer shall require counsel for the parties to prepare a daily topical index which will be available to the presiding officer and all parties. Preparation of such an index shall be apportioned among all counsel present in such manner as appears just and proper in the circumstances.

(b) The index should include each topic of testimony upon which evidence is taken, the name of each witness testifying upon the topic, the page of the record at which each portion of his testimony appeared, and the number of each exhibit relating to the topic. index should also contain the name of each witness, followed by the topics upon which he testified and the page of the record at which such testimony appears. § 180.24 Certification of record.

The

At the close of the hearing, the presiding officer shall afford interested persons a short time (not longer than 1 week, except in unusual cases) in which to