words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language.

(3) If the labeling contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear on the labeling in the foreign language.

(Sec. 602, 52 Stat. 1054, as amended; 21 U.S.C. 362) [20 F.R. 9537, Dec. 20, 1955, as amended at 21 FR. 2719, Apr. 27, 1956]

§ 1.204 Cosmetic; labeling requirements; exemptions.

(a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a cosmetic which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling requirements of sections 601(a) and 602(b) of the act if:

(1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such cosmetic is to be processed, labeled, or repacked; or

(2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post-office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such cosmetic in such establishment as will insure, if such specifications are followed, that such cosmetic will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such cosmetic from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them.

(b) An exemption of a shipment or other delivery of a cosmetic under paragraph (a) (1) of this section shall, at

the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment, become void ab initio if the cosmetic comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed.

(c) An exemption of a shipment or other delivery of a cosmetic under paragraph (a) (2) of this section shall become void ab initio with respect to the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to make available for inspection a copy of the agreement, as required by such clause.

(d) An exemption of a shipment or other delivery of a cosmetic under paragraph (a) (2) of this section shall expire:

(1) At the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment if the cosmetic comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed; or

(2) Upon refusal by the operator of the establishment where such cosmetic is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required by such clause.

(Sec. 603, 52 Stat. 1054, as amended: 21 U.S.C. 363) [20 FR. 9538, Dec. 20, 1955, as amended at 22 F.R. 891, Feb. 13, 1957]

IMPORTS AND EXPORTS

AUTHORITY: §§ 1.315 to 1.322 issued under sec. 701, 801, 52 Stat. 1055, as amended, 1058, as amended; 21 U.S.C. 371, 381, unless otherwise noted.

For the purposes of regulations prescribed under section 801 (a), (b), and (c) of the Federal Food, Drug, and Cosmetic Act:

(a) The term "owner" or "consignee" means the person who has the rights of a consignee under the provisions of sections 483, 484, and 485 of the Tariff Act of 1930, as amended (19 U. S. C. 1483, 1484 1485).

(b) The term "district director" means the director of the district of the Food and Drug Administration having jurisdiction over the port of entry through which an article is imported or offered for import, or such officer of the district as he may designate to act in his behalf

in administering and enforcing the provisions of section 801 (a), (b), and (c). [20 F.R. 9526, Dec. 20, 1955, as amended at 31 F.R. 8521, June 18, 1966]

§ 1.316 Notice of sampling.

When a sample of an article offered for import has been requested by the district director, the collector of customs having jurisdiction over the article shall give to the owner or consignee prompt notice of delivery of, or intention to deliver, such sample. Upon receipt of the notice, the owner or consignee shall hold such article and not distribute it until further notice from the district director or the collector of customs of the results of examination of the sample.

[20 F.R. 9526, Dec. 20, 1955, as amended at 31 F.R. 8521, June 18, 1966]

§ 1.317 Payment for samples.

The Food and Drug Administration will pay for all import samples which are found to be in compliance with the requirements of the Federal Food, Drug, and Cosmetic Act. Billing for reimbursement should be made by the owner or consignee to the Food and Drug Administration district headquarters in whose territory the shipment was offered for import. Payment for samples will not be made if the article is found to be in violation of the act, even though subsequently brought into compliance under the terms of an authorization to bring the article into compliance or rendered not a food, drug, device, or cosmetic as set forth in § 1.319.

(a) If it appears that the article may be subject to refusal of admission, the district director shall give the owner or consignee a written notice to that effect, stating the reasons therefor. The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony. Upon timely request, giving reasonable grounds therefor, such time and place may be changed. Such testimony shall be confined to matters relevant to the admissibility of the article, and may be introduced orally or in writing.

(b) If such owner or consignee submits or indicates his intention to submit an application for authorization to relabel or perform other action to bring the article into compliance with the act or to render it other than a food, drug,

device, or cosmetic, such testimony shall include evidence in support of such application. If such application is not submitted at or prior to the hearing, the district director shall specify a time limit, reasonable in the light of the circumstances, for filing such application. [20 F.R. 9526, Dec. 20, 1955, as amended at 31 F.R. 8521, June 18, 1966]

§ 1.319 Application for authorization.

Application for authorization to relabel or perform other action to bring the article into compliance with the act or to render it other than a food, drug, device or cosmetic may be filed only by the owner or consignee, and shall:

(a) Contain detailed proposals for bringing the article into compliance with the act or rendering it other than a food, drug, device, or cosmetic.

(b) Specify the time and place where such operations will be carried out and the approximate time for their completion.

§ 1.320 Granting of authorization.

(a) When authorization contemplated by § 1.319 is granted, the district director shall notify the applicant in writing, specifying:

(1) The procedure to be followed;

(2) The disposition of the rejected articles or portions thereof;

(3) That the operations are to be carried out under the supervision of an officer of the Food and Drug Administration or the Bureau of Customs, as the case may be;

(4) A time limit, reasonable in the light of the circumstances, for completion of the operations; and

are

(5) Such other conditions as necessary to maintain adequate supervision and control over the article.

(b) Upon receipt of a written request for extension of time to complete such operations, containing reasonable grounds therefor, the district director may grant such additional time as he deems necessary.

(c) An authorization may be amended upon a showing of reasonable grounds therefor and the filing of an amended application for authorization with the district director.

(d) If ownership of an article covered by an authorization changes before the operations specified in the authorization have been completed, the original owner will be held responsible, unless the new owner has executed a bond and obtained

(a) The bonds required under section 801(b) of the act may be executed by the owner or consignee on the appropriate form of a customs single-entry or term bond, containing a condition for the redelivery of the merchandise or any part thereof upon demand of the collector of customs and containing a provision for the performance of conditions as may legally be imposed for the relabeling or other action necessary to bring the article into compliance with the act or rendering it other than a food, drug, device, or cosmetic, in such manner as is prescribed for such bond in the customs regulations in force on the date of request for authorization. The bond shall be filed with the collector of customs.

(b) The collector of customs may cancel the liability for liquidated damages incurred under the above-mentioned provisions of such a bond, if he receives an application for relief therefrom, upon the payment of a lesser amount or upon such other terms and conditions as shall be deemed appropriate under the law and in view of the circumstances, but the collector shall not act under this regulation in any case unless the district director is in full agreement with the action.

[20 F.R. 9526, Dec. 20, 1955 as amended at 31 F.R. 8521, June 18, 1966]

§ 1.322

Costs chargeable in connection with relabeling and reconditioning inadmissible imports.

The cost of supervising the relabeling or other action in connection with an import of food, drugs, devices, or cosmetics which fails to comply with the Federal Food, Drug, and Cosmetic Act shall be paid by the owner or consignee who files an application requesting such action and executes a bond, pursuant to section 801 (b) of the act, as amended. The cost of such supervision shall include, but not be restricted to, the following:

(a) Travel expenses of the supervising officer.

(b) Per diem in lieu of subsistence of the supervising officer when away from his home station, as provided by law.

(c) Services of the supervising officer, to be calculated at a flat rate of $8 per hour (which shall include administrative expense), except that such services performed by a customs officer and subject to the provisions of the Act of February 13, 1911, as amended (sec. 5, 36 Stat. 901 as amended; 19 U.S.C. 267), shall be calculated as provided in that act.

(d) Services of analyst, to be calculated at a flat rate of $10 per hour (which shall include the use of the chemical laboratories and equipment of the Food and Drug Administration).

(e) The minimum charge for services of supervising officers and of analysts shall be not less than the charge for 1 hour, and time after the first hour shall be computed in multiples of 1 hour, disregarding fractional parts less than 1⁄2 hour.

[20 F.R. 9539, Dec. 20, 1955, as amended at 30 F.R. 5507, Apr. 17, 1965]

(a) (1) When any officer or employee of the Department collects a sample of a food, drug, or cosmetic for analysis under the act, the sample shall be designated as an official sample if records or other evidence is obtained by him or any other officer or employee of the Department indicating that the shipment or other lot of the article from which such sample was collected was introduced or delivered for introduction into interstate commerce, or was in or was received in interstate commerce, or was manufactured within a Territory. Only samples so designated by an officer or employee of the Department shall be considered to be official samples.

(2) For the purpose of determining whether or not a sample is collected for analysis, the term "analysis" includes examinations and tests.

(3) The owner of a food, drug, or cosmetic of which an official sample is collected is the person who owns the shipment or other lot of the article from which the sample is collected.

(b) When an officer or employee of the Department collects an official sample of a food, drug, or cosmetic for analysis under the act, he shall collect at least twice the quantity estimated by him to be sufficient for analysis, unless:

(1) The amount of the article available and reasonably accessible for sam

pling is less than twice the quantity so estimated;

(2) The cost of twice the quantity so estimated exceeds $10;

(3) The article is perishable;

(4) The sample is collected from a shipment or other lot which is being imported or offered for import into the United States;

(5) The sample is collected from a person named on the label of the article, or his agent, and such person is also the owner of the article;

(6) The sample is collected from the owner of the article, or his agent, and such article bears no label or, if it bears a label, no person is named thereon; or (7) The analysis consists principally of rapid analytical procedures, organoleptic examination, or other field inspection examinations or tests, made at the place where the sample is collected or in a mobile or temporary laboratory. In addition to the quantity of sample prescribed above the officer or employee shall, if practicable, collect as part of the sample such further amount of the article as he estimates to be sufficient for use as exhibits in the trial of any case that may arise under the act based on the sample.

(c) After the Food and Drug Administration has completed such analysis of an official sample of a food, drug, or cosmetic as it determines, in the course of analysis and interpretation of analytical results, to be adequate to establish the respects, if any, in which the article is adulterated or misbranded within the meaning of the act, or otherwise subject to the prohibitions of the act, and has reserved an amount of the article it estimates to be adequate for use as exhibits in the trial of any case that may arise under the act based on the sample, a part of the sample, if any remains available, shall be provided for analysis, upon written request, by any person named on the label of the article, or the owner thereof, or the attorney or agent of such person or owner, except when:

(1) After collection, the sample or remaining part thereof has become decom. posed or otherwise unfit for analysis, or

(2) The request is not made within a reasonable time before the trial of any case under the act, based on the sample, to which such person or owner is a party. The person, owner, attorney, or agent who requests the part of sample shall

specify the amount desired. A request from an owner shall be accompanied by a showing of ownership, and a request from an attorney or agent by a showing of authority from such person or owner to receive the part of sample. When two or more requests for parts of the same sample are received the requests shall be complied with in the order in which they were received so long as any part of the sample remains available therefor.

(d) When an official sample of a food, drug, or cosmetic is the basis of a notice given under section 305 of the act, or of a case under the act, and the person to whom the notice was given, or any person who is a party to the case, has no right under paragraph (c) of this section to a part of the sample, such person or his attorney or agent may obtain a part of the sample upon request accompanied by a written waiver of right under such paragraph (c) from each person named on the label of the article and owner thereof, who has not exercised his right under such paragraph (c). The operation of this paragraph shall be subject to the exceptions, terms, and conditions prescribed in paragraph (c) of this section.

(e) The Food and Drug Administration is authorized to destroy:

(1) Any official sample when it determines that no analysis of such sample will be made;

(2) Any official sample or part thereof when it determines that no notice under section 305 of the act, and no case under the act, is or will be based on such sample;

(3) Any official sample or part thereof when the sample was the basis of a notice under section 305 of the act, and when, after opportunity for presentation of views following such notice, it determines that no other such notice, and no case under the act, is or will be based on such sample;

(4) Any official sample or part thereof when the sample was the basis of a case under the act which has gone to final judgment, and when it determines that no other such case is or will be based on such sample;

(5) Any official sample or part thereof if the article is perishable;

(6) Any official sample or part thereof when, after collection, such sample or part has become decomposed or otherwise unfit for analysis;