(a)

(1) The affected manufacturer, laboratory or third-party certifier may request a hearing under this section within 30 days following receipt of the required notification in any case where the Administrator—

(i) Denies an application for a certificate of compliance under §60.533(c) or §60.533(f);

(ii) Denies an application for a renewal of certification under §60.533(i);

(iii) Issues a notice of revocation of certification under §60.533(1);

(iv) Denies an application for laboratory approval under §60.535(a);

(v) Issues a notice of revocation of laboratory approval under §60.535(b);

(vi) Denies an application for third-party certifier approval under §60.535(d); or

(vii) Issues a notice of revocation of third-party certifier approval under §60.535(e).

(2) In any case where the Administrator issues a notice of revocation under §60.533(n)(3)(ii), the manufacturer may request a hearing under this section with the time limits set out in §60.533(n)(3)(ii).

(b) Any hearing request must be in writing, must be signed by an authorized representative of the petitioning manufacturer or laboratory and must include a statement setting forth with particularity the petitioner's objection to the Administrator's determination or proposed determination.

(c)

(1) Upon receipt of a request for a hearing under paragraph (a) of this section, the Administrator will request the Chief Administrative Law Judge to designate an Administrative Law Judge as Presiding Officer for the hearing. If the Chief Administrative Law Judge replies that no Administrative Law Judge is available to perform this function, the Administrator will designate a Presiding Officer who has not had any prior responsibility for the matter under review, and who is not subject to the direct control or supervision of someone who has had such responsibility.

(2) The hearing will commence as soon as practicable at a time and place fixed by the Presiding Officer.

(3)

(i) A motion for leave to intervene in any proceeding conducted under this section must set forth the grounds for the proposed intervention, the position and interest of the movant and the likely impact that intervention will have on the expeditious progress of the proceeding. Any person already a party to the proceeding may file an answer to a motion to intervene, making specific reference to the factors set forth in the foregoing sentence and paragraph (c)(3)(iii) of this section, within 10 days after service of the motion for leave to intervene.

(ii) A motion for leave to intervene in a proceeding must ordinarily be filed before the first prehearing conference or, in the absence of a prehearing conference, prior to the setting of a time and place for a hearing. Any motion filed after that time must include, in addition to the information set forth in paragraph (c)(3)(i) of this section, a statement of good cause for the failure to file in a timely manner. The intervener shall be bound by any agreements, arrangements and other matters previously made in the proceeding.

(iii) A motion for leave to intervene may be granted only if the movant demonstrates that his presence in the proceeding would not unduly prolong or otherwise prejudice the adjudication of the rights of the original parties, and that movant may be adversely affected by a final order. The intervener will become a full party to the proceeding upon the granting of leave to intervene.

(iv) Persons not parties to the proceeding may move for leave to file amicus curiae briefs. The movant must state his interest and the reasons why the proposed amicus brief is desirable. If the motion is granted, the Presiding Officer or Administrator will issue an order setting the time for filing such brief. An amicus curia may participate in any briefing after his motion is granted, and will be served with all briefs, reply briefs, motions and orders relating to issues to be briefed.

(4) In computing any period of time prescribed or allowed in this subpart, the day of the event from which the designated period begins to run will not be included. Saturdays, Sundays and federal legal holidays will be included. When a stated time expires on a Saturday, Sunday or legal holiday, the stated time period will be extended to include the next business day.

(d)

(l) Upon his appointment, the Presiding Officer must establish a hearing file. The file will consist of the notice issued by the Administrator under §60.533(c)(2), §60.533(f)(3), §60.533(i)(4), §60.533(l)(2), §60.533(n)(3)(ii)(A), §60.535(a)(3), §60.535(b)(2), §60.535(d)(3) or §60.535(e)(2) together with any accompanying material, the request for a hearing and the supporting data submitted therewith, and all documents relating to the request for certification or approval or the proposed revocation of either.

(2) The hearing file must be available for inspection by any party, to the extent authorized by law, at the office of the Presiding Officer, or other place designated by him.

(e) Any party may appear in person, or may be represented by counsel or by any other duly authorized representative.

(f)

(1) The Presiding Officer upon the request of any party, or at his discretion, may order a prehearing conference at a time and place specified by him to consider the following:

(i) Simplification of the issues,

(ii) Stipulations, admissions of fact, and the introduction of documents,

(iii) Limitation of the number of expert witnesses,

(iv) Possibility of agreement disposing of all or any of the issues in dispute,

(v) Such other matters as may aid in the disposition of the hearing, including such additional tests as may be agreed upon by the parties.

(2) The results of the conference must be reduced to writing by the Presiding Officer and made part of the record.

(g)

(1) Hearings will be conducted by the Presiding Officer in an informal but orderly and expeditious manner. The parties may offer oral or written evidence, subject to the exclusion by the Presiding Officer of irrelevant, immaterial and repetitious evidence.

(2) Witnesses will not be required to testify under oath. However, the Presiding Officer will call to the attention of witnesses that their statements may be subject to penalties under title 18 U.S.C. 1001 for knowingly making false statements or representations or using false documents in any matter within the jurisdiction of any department or agency of the United States.

(3) Any witness may be examined or cross-examined by the Presiding Officer, the parties or their representatives.

(4) Hearings must be recorded verbatim. Copies of transcripts of proceedings may be purchased by the applicant from the reporter.

(5) All written statements, charts, tabulations and similar data offered in evidence at the hearings must, upon a showing satisfactory to the Presiding Officer of their authenticity, relevancy and materiality, be received in evidence and will constitute a part of the record.

(h)

(1) The Presiding Officer will make an initial decision which must include written findings and conclusions and the reasons or basis therefor on all the material issues of fact, law or discretion presented on the record. The findings, conclusions and written decision must be provided to the parties and made a part of the record. The initial decision will become the decision of the Administrator without further proceedings unless there is an appeal to the Administrator or motion for review by the Administrator. Except as provided in paragraph (h)(3) of this section, any such appeal must be taken within 20 days of the date the initial decision was filed.

(2) On appeal from or review of the initial decision, the Administrator will have all the powers which he would have in making the initial decision including the discretion to require or allow briefs, oral argument, the taking of additional evidence or the remanding to the Presiding Officer for additional proceedings. The decision by the Administrator must include written findings and conclusions and the reasons or basis therefor on all the material issues of fact, law or discretion presented on the appeal or considered in the review.

(3) In any hearing requested under paragraph (a)(2) of this section the Presiding Officer must render the initial decision within 60 days of that request. Any appeal to the Administrator must be taken within 10 days of the initial decision, and the Administrator must render a decision in that appeal within 30 days of the filing of the appeal.