the District of Columbia to another State or Territory or the District of Columbia without a permit issued by the Secretary and in compliance with the terms thereof: Provided, That no permit shall be required under this section for importation of organisms for which an import permit has been issued pursuant to Part 102 of this subchapter or for transportation of organisms produced at establishments licensed under Part 102 of this subchapter. As a condition of issuance of permits under this section, the permittee shall agree in writing to observe the safeguards prescribed by the Director for public protection with respect to the particular importation or transportation. [28 F.R. 7896, Aug. 2, 1963. Redesignated at 31 FR. 81, Jan. 5, 1966] § 122.3 Application for permits. The Secretary may issue, at his discretion, a permit as specified in § 122.2 when proper safeguards are set up as provided in § 122.2 to protect the public. Application for such a permit shall be made in advance of shipment, and each permit shall specify the name and address of the consignee, the true name and character of each of the organisms or vectors involved, and the use to which each will be put. [23 F.R. 10065, Dec. 23, 1958. Redesignated at 31 F.R. 81, Jan. 5, 1966] § 122.4 Suspension or revocation of permits. (a) Any permit for the importation or transportation of organisms or vectors issued under this part may be formally suspended or revoked after opportunity for hearing has been accorded the permittee, as provided in Part 123 of this subchapter, if the Secretary finds that the permittee has failed to observe the safeguards and instructions prescribed by the Director with respect to the particular importation or transportation or that such importation or transportation for any other reason may result in the introduction or dissemination from a foreign country into the United States, or from one State, Territory or the District of Columbia to another, of the contagion of any contagious, infectious or communicable disease of animals (including poultry). (b) In cases of wilfulness or where the public health, interest or safety so requires, however, the Secretary may without hearing informally suspend such a 123.12 The examiner's report. 123.13 123.14 123.15 123.16 123.17 123.18 123.19 The shortened procedure. Transmittal of record. Preparation and issuance of order. Hearings before Secretary. Filing; service; extensions of time; additional time for filing; and computation of time. AUTHORITY: The provisions of this Part 123 issued under sec. 2, 32 Stat. 792, 37 Stat. 832-833; 21 U.S.C. 111, 151–158. SOURCE: The provisions of this Part 123 appear at 28 F.R. 10065, Dec. 23, 1958; 31 F.R. 82, Jan. 5, 1966, unless otherwise noted. § 123.1 Definitions. The following words, when used in this part, shall be construed, respectively, to mean: The act (a) Virus-Serum-Toxin Act. of Congress of March 4, 1913, 37 Stat. 832-833, 21 U. S. C. 151–158. (b) Section 2 of the act of February 2, 1903. Section 2 of the act of Congress of February 2, 1903, 32 Stat. 791, as amended, 21 U. S. C. 111. (c) Regulations. The provisions in Parts 101 through 122 of this subchapter. (d) Department. The United States Department of Agriculture. (e) Division. Veterinary Biologics Division of the Department. (f) [Reserved] (g) Secretary. "Secretary" means the Secretary of Agriculture of the United States, or any officer or employee of the Department to whom authority has heretofore been delegated, or to whom authority may hereafter be delegated, to act in his stead. (h) Director. The Director of the Division or any other officer or employee of the Division to whom authority has heretofore lawfully been delegated, or may hereafter lawfully be delegated, to act in his stead. (i) Licensee. A person to whom a license to manufacture biological products has been issued under the regulations. (j) Permittee. A person who resides in the United States, or operates a business establishment within the United States, to whom a permit to import or transport biological products or organisms or vectors has been issued under the regulations. (k) Hearing clerk. The Hearing clerk, United States Department of Agriculture, Washington, D. C. (1) Examiner. Any examiner in the Office of Hearing Examiners, United States Department of Agriculture. (m) Complainant. The party upon whose order to show cause a formal proIceeding is instituted. (n) Respondent. The party proceeded against. (0) Hearing. That part of a proceeding under the rules in this part which involves the submission of evidence, either orally or in writing. (p) Examiner's report. The examiner's report to the Secretary, including the examiner's proposed (1) findings of fact and conclusions with respect to all material issues of fact, law, or discretion, as well as the reasons or basis therefor, (2) order, and (3) rulings on findings, conclusions, and orders submitted by the parties. (q) Biological products. All viruses, serums, toxins, and analogous products, such as antitoxins, vaccines, tuberculins, malleins, live microorganisms, killed microorganisms, and products of microorganisms, intended for use in the treatment of domestic animals, including the diagnosis or detection of diseases of such animals. (r) Organisms. All cultures or collections of organisms or their derivatives, which may introduce or disseminate any contagious or infectious disease of animals (including poultry). (s) Vectors. All animals (including poultry), such as mice, pigeons, guinea pigs, rats, ferrets, rabbits, chickens, dogs, and the like, which have been treated or inoculated with organisms, or which are diseased or infected with any contagious, infectious, or communicable disease of animals or poultry or which have been exposed to any such disease. [23 F.R. 10065, Dec. 23, 1958, as amended at 26 FR. 7727, Aug. 18, 1961] § 123.2 Proceedings to which rules apply. The rules of practice in this part shall apply to formal proceedings for the suspension or revocation of licenses or permits under the regulations and, in so far as appropriate, to proceedings against a representative of any party under § 123.10 (c) (1). § 123.3 Procedure prior to institution of formal proceedings. In all cases except those involving willfulness or in which the public health, interest, or safety otherwise requires, prior to the institution of a formal proceeding under this part, the Director, in an effort to effect an amicable or informal adjustment of the matter, shall give written notice to the licensee, permittee, or other persons involved, of the facts or conduct which appear to warrant institution of such a proceeding and shall afford such person an opportunity, within a reasonable time fixed by the Director, to demonstrate or achieve compliance with the applicable requirements of the Virus-Serum-Toxin Act, section 2 of the act of February 2, 1903, and the regulations. In any case in which compliance is demonstrated or achieved, no formal proceedings shall be instituted. § 123.4 Stipulations and consent orders. (a) Stipulation of compliance. At any time prior to the issuance of the order to show cause in any proceeding, the Secretary, in his discretion, may enter into a stipulation with the prospective respondent, whereby the latter admits the material facts and agrees to discontinue the acts or practices complained of. Such stipulations shall be admissible as evidence of such acts and practices in any subsequent proceeding against such person before the Secretary. (b) Consent order. At any time after the issuance of the order to show cause and prior to the hearing in any proceeding, the Secretary, in his discretion, may allow the respondent to consent to an order. Upon a record composed of the order to show cause and a stipulation made for the record by the respondent (a) Filing, service, and contents. If a case is not disposed of under the procedure described in § 123.3 or § 123.4 (a), the Director may institute formal proceedings by filing an order to show cause, in triplicate, with the hearing clerk, who promptly shall serve a true copy thereof upon the respondent, as provided in § 123.19 (b). The order to show cause shall be addressed to the respondent, shall state briefly and clearly the allegations of fact which constitute a basis for the proceeding, and the legal authority and jurisdiction under which the proceeding is instituted, and shall specify with particularity the matters in issue. The order to show cause shall not include charges, implied charges, or requirements phrased generally in the words of the Virus-Serum-Toxin Act or the Act of February 2, 1903, but such acts may be identified and quoted or used in preliminary recitals. (b) Amendments. At any time prior to the close of the hearing, the order to show cause may be amended, but, in case of an amendment adding new provisions, the hearing shall, at the request of the respondent, be adjourned for a period not exceeding 15 days. Amendments subsequent to the first amendment or subsequent to the filing of an answer by the respondent may be made only with leave of the examiner or with the written consent of the adverse party. (c) Docketing. Each proceeding immediately following its institution shall be assigned a docket number by the hearing clerk, and thereafter the proceeding shall be referred to by such number. and any other party of record, in the manner provided in § 123.19 (b). (b) Contents; failure to file answer. (1) The answer shall (i) contain a statement of the facts which constitute the grounds of defense, and shall specifically admit, deny, or explain each of the allegations of the order to show cause unless respondent is without knowledge, in which case the answer shall so state; or (ii) state that the respondent admits all of the allegations of the order to show cause. The answer may contain a waiver of hearing. (2) Failure to file an answer to or plead specifically to any allegation of the order to show cause shall constitute an admission of such allegation. (c) Admission of facts. The admission, in the answer or by failure to file an answer, of all the material allegations of fact contained in the order to show cause shall constitute a waiver of hearing. Upon such admission of facts, the examiner, without further investigation or hearing, shall prepare his report, in which he shall adopt as his proposed findings of fact the material facts alleged in the order to show cause. Unless the parties have waived service of the examiner's report, it shall be served upon them in the manner provided in § 123.19 (b). The parties shall be given an opportunity to file exceptions to the report, to file briefs in support of such exceptions, and to make oral argument thereon before the Secretary. Any request to make oral argument before the Secretary must be filed in the manner and within the time provided in § 123.15. § 123.7 Motions and requests. Any motion will be entertained except a motion to dismiss on the pleadings. All motions and requests shall be filed in triplicate with the Hearing Clerk, except that those made during the course of an oral hearing may be filed with the examiner or may be stated orally and made a part of the transcript. 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 this part. The Secretary will rule upon all motions and requests filed after that time. The submission of any motion, request, objection, or other question to the Secretary prior to the time when the examiner's report is filed with the Hearing Clerk shall be in the discretion of the examiner. § 123.8 Examiners. (a) Assignment. No examiner shall be assigned to serve in any proceeding who (1) has any pecuniary interest in any matter or business involved in the proceeding, (2) is related within the third degree by blood or marriage to any party to the proceeding, or (3) has participated in the investigation preceding the institution of the proceeding, or in the determination that it should be instituted, or in the preparation of the order to show cause, or in the development of the evidence to be introduced therein. (b) Disqualification. (1) Any party may file with the hearing clerk a timely affidavit of disqualification of the examiner, which shall set forth with particularity the grounds of alleged disqualification. After such investigation or hearing as the Secretary shall deem necessary, he may find the affidavit without merit or may direct that another examiner be assigned to the proceeding. Where the affidavit is found without merit, the affidavit, any record made thereon, and the finding and order of the Secretary shall be made a part of the record. (2) An examiner shall ask to be withdrawn from any proceeding in which he deems himself disqualified for any reason. (c) Conduct. The examiner shall conduct the proceeding in a fair and impartial manner, and save to the extent required for the disposition of ex parte matters as authorized by law, he shall not consult any person or party on any fact in issue unless upon notice and opportunity for all parties to participate. (d) Powers. Subject to review by the Secretary as provided elsewhere in this part, the examiner, in any proceeding assigned to him, shall have power to: (1) Rule upon motions and requests; (2) set the time and place of hearing, adjourn the hearing from time to time and change the time and place of hearing; (3) administer oaths and affirmations and take affidavits; (4) examine witnesses and receive evidence; (5) take or order, under the facsimile signature of the Secretary, the taking of, depositions; (6) admit or exclude evidence; (7) hear oral argument on facts or law; and (8) do all acts and take all measures necessary for the maintenance of order and the efficient conduct of the proceeding. (e) Who may act in absence of the examiner. In case of the absence of the examiner or his inability to act, the powers and duties to be performed by him under this part in connection with a proceeding assigned to him may, without abatement of the proceeding unless otherwise directed by the Secretary, be assigned to any other examiner. § 123.9 Prehearing conferences. In any proceeding in which it appears that such procedure will expedite the proceeding, the examiner, at any time prior to the commencement of the oral hearing, may request the parties or their counsel to appear at a conference before him to consider (a) the simplification of issues; (b) the necessity or desirability of amendments to pleadings; (c) the possibility of obtaining stipulations of fact and of documents which will avoid unnecessary proof; (d) the limitation of the number of expert or other witnesses; and (e) such other matters as may expedite and aid in the disposition of the proceeding. No transcript of such conference shall be made, but the examiner shall prepare and file for the record a written summary of the action taken at the conference, which shall incorporate any written stipulations or agreements made by the parties at the conference or as a result of the conference. If the circumstances are such that a conference is impracticable, the examiner may request the parties to correspond with him for the purpose of accomplishing any of the objects set forth in this section. The examiner shall forward copies of letters and documents to the parties as the circumstances require. Correspondence in such negotiations shall not be a part of the record, but the examiner shall submit a written summary for the record if any action is taken. § 123.10 Oral hearing before examiner. (a) Request for oral hearing. Any party may request an oral hearing on the facts by including such request in the order to show cause or the answer or by a separate request in writing filed with the hearing clerk. Failure to request an oral hearing within the time allowed for the filing of the answer shall constitute a waiver of such hearing, and the party so failing to request an oral hearing will be deemed to have agreed that the proceeding may be decided upon a record formed under the shortened procedure provided in § 123.13. Waiver of oral hearing shall not be deemed to be a waiver of the right to make oral argument before the Secretary upon exceptions to the examiner's report. Such argument will be allowed in accordance with the provisions of § 123.15. (b) Time and place. If and when the proceeding has reached the stage where an oral hearing is to be held, the examiner, giving careful consideration to the convenience of the parties, shall set a time and place for hearing and shall file with the hearing clerk a notice stating the time and place of hearing. If any change in the time or place of the hearing is made, the examiner shall file with the hearing clerk a notice of such change, which notice shall be served upon the parties, unless the change is made during an oral hearing and made a part of the transcript. (c) Appearances (1) Representation. In any proceeding under the regulations, the parties may appear in person or by counsel or other representative. The Director, if represented by counsel, shall be represented by an attorney assigned by the Solicitor of the Department. Persons who appear as counsel or in any other representative capacity at a hearing must conform to the standards of ethical conduct required of practitioners before the courts of the United States. Whenever the Secretary finds, after notice and opportunity for hearing, that a person, who is acting or has acted as counsel or other representative for another person in any proceeding before the Secretary, is unfit to act as such counsel or other representative, he will order that such person be precluded from acting as counsel or other representative in any proceeding under this part. The procedure in such case will be governed by the applicable provisions of the rules of practice in this part. (2) Failure to appear. (1) If any party to the proceeding, after being duly notified, fails to appear at the hearing, he shall be deemed to have waived the right to an oral hearing in the proceeding. In the event that a party appears at the hearing and no party appears for the opposing side, the party who is present shall have an election whether to present his evidence, in whole or in part, in the form of affidavits or by oral testimony before the examiner. (ii) Failure to appear at a hearing shall not be deemed to be a waiver of the right to be served with a copy of the examiner's report and to file exceptions and make oral argument before the Secretary with respect thereto, in the manner provided hereinafter. (d) Order of proceeding. Except as may be determined otherwise by the examiner, the complainant shall proceed first at the hearing. (e) Evidence-(1) In general. (i) The testimony of witnesses at a hearing shall be upon oath or affirmation and subject to cross-examination. (ii) Any witness may, in the discretion of the examiner, be examined separately and apart from all other witnesses except those who may be parties to the proceeding. (iii) The examiner shall exclude evidence which is immaterial, irrelevant, or unduly repetitious, or which is not of the sort upon which responsible persons are accustomed to rely. (2) Objections. (i) If a party objects to the admission or rejection of any evidence or to the limitation of the scope of any examination or cross-examination, he shall state briefly the grounds of such objection, whereupon an automatic exception will follow if the objection is overruled by the examiner. The transcript shall not include argument or debate thereon except as ordered by the examiner. The ruling of the examiner on any objection shall be a part of the transcript. (ii) Only objections made before the examiner may subsequently be relied upon in the proceeding. (3) Depositions. The deposition of any witness shall be admitted, in the manner provided in and subject to the provisions of § 123.11. (4) Affidavits. Except as is otherwise provided in the rules in this part, affidavits may be admitted only if the evidence is otherwise admissible and the parties agree that affidavits may be used. (5) Proof of documents. A true copy of every written entry in the records of the Department, made by an officer or employee thereof in the course of his official duty, and relevant to the issues involved in the hearing, shall be admissible as prima facie evidence of the facts stated therein, without the production of such officer or employee. (6) Exhibits. Except where the examiner finds that the furnishing of copies is impracticable, a copy of each exhibit, in addition to the original, shall be filed with the examiner for the use of each other party to the proceeding. The examiner shall advise the parties as |