Department of Agriculture or by registered mail, return receipt requested. If the respondent is a corporation, service shall be had upon the president, secretary, treasurer or statutory agent of the corporation. (d) The Secretary shall set a time and place for a hearing upon the order to show cause. (e) The Secretary shall designate an employee of the Department of Agriculture as examiner to conduct the hearing, and such examiner may, in accordance with the rules of evidence applicable to administrative proceedings, admit or exclude any evidence presented and may limit the scope of any evidence admitted. The respondent may appear in person or by counsel. All persons who appear at the hearing must conform to the standards of ethical conduct required of practitioners before the courts of the United States. The testimony of the witnesses at the hearing shall be upon oath or affirmation administered by the examiner. Copies of the records of the Department of Agriculture, certified under the seal of the Department, shall be admissible to the same extent that the original records would be admissible. The deposition of any witness, taken after reasonable notice to the opposite party and at a time and place and before a person designated for the purpose by the Secretary, shall be admitted if the evidence is otherwise admissible. Affidavits, if relevant and material, may, in the discretion of the examiner, be admitted, but the Secretary will consider the lack of opportunity for cross-examination in determining the weight that shall be given to such evidence. Hearsay evidence may, in the discretion of the examiner, be admitted even though it does not come within any well-recognized exception to the hearsay rule, but the Secretary will determine what weight shall be given to such evidence. The form of the introduction of evidence shall not be a ground for objecting to such evidence. When practicable to do so, a copy of each exhibit shall be furnished to the opposing party either before or at the time of its introduction. Judicial notice, on request, will be taken of such matters as are noticed by the courts of the United States. If the respondent objects to the admission of any evidence offered against him or the rejection of any evidence offered by him, or to the limitation of the scope of any evidence introduced by him, he shall state the grounds of such objection. If the objection is overruled, he may take an exception. (f) At the hearing, the Department shall be represented by an attorney designated by the Solicitor of the Department. (g) At the conclusion of the hearing, the examiner shall announce the period of time within which briefs may be filed following the receipt by the respondent of the tentative findings of fact and the tentative order, as set out in paragraph (h). Page 253 (h) The examiner, within a reasonable time after the conclusion of the hearing, shall prepare tentative findings of fact and a tentative order, which shall be served upon the respondent or sent to him by registered mail. (i) Within 20 days after the receipt of the tentative findings of fact and the tentative order, the respondent, if he wishes to take exceptions to any matters set out therein, shall transmit such exceptions to the Solicitor of the Department of Agriculture. At the same time, the respondent shall transmit a brief statement concerning each of the exceptions to the actions of the examiner at the hearing, as set out in paragraph (e), upon which he wishes to rely. If exception is taken to any proposed finding of fact, reference must be made to the pages or parts of the record relied upon and a corrected finding of fact must be submitted. The respondent, if he files exceptions, shall state in writing whether he desires to make an oral argument on the exceptions before the Secretary. (j) In the event that an oral argument before the Secretary is requested, a date for such argument shall be fixed by the Secretary or by the Under Secretary, or Assistant Secretary, if designated by the Secretary to act in his stead. (k) If oral argument is heard in any proceedings by the Secretary or Acting Secretary, the final order in the proceeding shall be issued by the person who heard the argument. (37 Stat. 832, 833; 21 U.S.C. 151–158) [Sec. order, Sept. 14, 1936, 1 F.R. 1363] PART 102-LICENSES AND PERMITS 102.26 Importers; valid and effective 102.77 Licensed establishments to fur permit required. nish facilities. Page 254 LICENSES AND INSPECTIONS Section 102.1 Establishments; requirements. Every establishment in the United States at which any virus, serum, toxin, or analogous product is prepared for sale, barter, or exchange in the District of Columbia or in any Territory of or place under the jurisdiction of the United States, or for shipment or delivery for shipment from any State or Territory or the District of Columbia to any other State or Territory or the District of Columbia, shall hold an unexpired, unsuspended, and unrevoked license, issued by the Secretary of Agriculture, and shall have inspection under the regulations in this subchapter.* [Reg. 2, sec. 1] *88 102.1 to 102.77, inclusive, issued under the authority contained in 37 Stat. 832, 833; 21 U.S.C. 151-158. †The source of §§ 102.1 to 102.76, inclusive, is BAI order 276, Aug. 18, 1922. 102.2 Biologic products to be prepared, etc., according to regulations. All viruses, serums, toxins, and analogous products produced at licensed establishments shall be prepared, handled, stored, marked, received for transportation, and transported as required by the regulations in this subchapter.** [Reg. 2, sec. 2] 102.3 Application for license; plans. (a) The proprietor or operator of each establishment of the kind specified in § 102.1 shall make application in writing to the Secretary of Agriculture for a license. When one proprietor conducts more than one establishment, a separate application shall be made for a license for each establishment. Blank forms of application will be furnished upon request addressed to the Bureau of Animal Industry, Washington, D. C. (b) Triplicate copies of plans, properly drawn to scale, and of specifications, including plumbing and drainage of establishments, together with triplicate copies of all labels and advertising matter to be used in connection with or relating to all viruses, serums, toxins, and analogous products prepared therein, shall accompany the application for a license, unless these plans, specifications, labels, and advertising matter have already been approved in writing by the Bureau. (c) In case of change in ownership or location while an application is pending, or after a license has been issued, a new application shall be made. [Reg. 2, sec. 3] 102.4 Conditions under which license will not issue. (a) A license will not be issued unless the condition of the establishment and the methods of preparation are such as reasonably to insure that the products will accomplish the object for which they are intended and that they are not worthless, contaminated, dangerous, or harmful. (b) A license will not be issued unless and until the establishment is prepared to operate under the direct supervision of a competent person trained in bacteriological technic or in the preparation of viruses, serums, toxins, or analogous products named in the application. (c) A license will not be issued for the preparation of any virus, serum, toxin, or analogous product if advertised so as to mislead or **For statutory and source citations, see note to § 102.1. Page 255 deceive the purchaser, or if the package or container in which the same is intended to be sold, bartered, exchanged, or shipped bears or contains any statement, design, or device which is false or misleading in any particular.* [Reg. 2, sec. 4] 102.5 When license will issue; number and form. (a) A license will be issued only after inspection of the establishment by a bureau employee has shown that the condition and equipment of the establishment and the methods of preparing, handling, and storing products are in conformity with the regulations in this subchapter. (b) Licenses shall be numbered and shall be in the following form: UNITED STATES VETERINARY LICENSE NO. 19- This is to certify that, pursuant to the terms of the Act of Congress approved March 4, 1913 (37 Stat. 832), governing the preparation, sale, barter, exchange, shipment, and importation of viruses, serums, toxins, and analogous products intended for use in the treatment of domestic animals, is hereby licensed to maintain at_-- the preparation of an establishment for This license is subject to termination as provided in the regulations made under the authority contained in said Act approved March 4, 1913, and also to suspension or revocation if the licensee violates or fails to comply with any provision of the said act or the regulations made thereunder. Countersigned: Chief, Bureau of Animal Industry. Secretary of Agriculture. (c) Two or more licenses may bear the same number when they are issued to firms under the same ownership or control, provided a serial letter is added when necessary to identify each license. (d) Should a licensed establishment discontinue the production of any virus, serum, toxin, or analogous product, the license of such establishment shall be returned to the bureau for termination and a new license issued covering such products named therein as the establishment shall continue to produce. Should an establishment be engaged in the preparation of products under a number of licenses issued from time to time by the department, the licenses shall be returned to the bureau at its request for termination and a new license issued covering all the products embraced in the returned licenses which the establishment shall continue to produce.** [Reg. 2, sec. 5] 102.6 Biologic products; preparation in licensed establishment by another licensed establishment prohibited. No viruses, serums, toxins, or analogous products shall be prepared in whole or in part in a licensed establishment by any other licensed establishment unless authorized in advance by the Chief of Bureau.*† [Reg. 2, sec. 6, par. 1] 102.7 Licensed and unlicensed establishments; separation required. Each licensed establishment shall be separate and distinct from any unlicensed establishment in which any virus, serum, toxin, or analogous product is prepared or handled.** [Reg. 2, sec. 6, par. 2] Page 256 **For statutory and source citations, see note to § 102.1. 102.8 Issuance of license; instructions to proprietor; restrictions on products prepared prior to issuance. When a license is issued the Bureau shall inform the proprietor or operator of the establishment of the requirements of the regulations in this subchapter. If the establishment, at the time the license is issued, has in possession any viruses, serums, toxins, or analogous products, which have not theretofore been prepared and of which the containers have not been theretofore marked in compliance with the regulations in this subchapter, the identity of the same shall be maintained and they shall not be shipped or delivered for shipment from one State or Territory or the District of Columbia to another State or Territory or the District of Columbia, or otherwise dealt with as products prepared under the regulations in this subchapter. The establishment shall adopt and enforce all necessary measures and shall comply with all such directions as the Chief of Bureau may prescribe for carrying out the purposes of this section.*t [Reg. 2, sec. 6, par. 3] PERMITS 102.26 Importers; valid and effective permit required. Each importer of viruses, serums, toxins, or analogous products shall hold an unexpired, unsuspended, and unrevoked permit issued by the Secretary of Agriculture.*+ [Reg. 3, sec. 1] 102.27 Application for permit; requirements and conditions. (a) Each importer of viruses, serums, toxins, and analogous products shall make application in writing to the Secretary of Agriculture for a permit. The application shall specify the port or ports of entry at which the imported articles will be cleared through the customs. Blank forms of application will be furnished upon request addressed to the Bureau of Animal Industry, Washington, D. C. (b) Each application for a permit shall be accompanied by the affidavit of the actual manufacturer produced before an American consular officer, giving the city or town where the viruses, serums, toxins, or analogous products mentioned therein are prepared, and stating that said products are not worthless, contaminated, dangerous, or harmful; whether the products were derived from animals, and, if so derived, the name of the species, and that such animals have not been exposed to any infectious or contagious disease, except as may have been essential in the preparation of the products and as specified in the affidavit. (c) Each application for a permit shall be accompanied by the written consent of the actual manufacturer that properly accredited employees of the department shall have the privilege of inspecting, without previous notification, all parts of the establishment at which such viruses, serums, toxins, or analogous products are prepared, and all processes of and all records kept relative to the preparation of such products at such times as may be demanded by the aforesaid employees. (d) Each application for permit shall be accompanied by triplicate copies of all labels and advertising matter.*t [Reg. 3, sec. 2] **For statutory and source citations, see note to § 102.1. Page 257 |