Authority: IC 16-19-3-4

Affected: IC 16-42-1

Sec. 1. (A) Except as provided by paragraphs (B) and (C) of this regulation, a shipment or other delivery of a food 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 commerce and the time of holding in such establishment, from compliance with the labeling requirements of Section 13 (c), (g), (h), (i), (j) and (k) of the Act if–

1. (1) the person who introduced such shipment or delivery into commerce is the operator of the establishment where such food is to be processed, labeled, or repacked; or
2. (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 address of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such food in such establishment as will insure, if such specifications are followed, that such food 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 all such shipment or delivery has been removed from such establishment, and shall make such copies available for inspection at any reasonable hour to the Secretary or his authorized agent who requests them.

(B) An exemption of a shipment or other delivery of a food under clause (1) of paragraph (A) of this regulation 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 food 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 food under clause (2) of paragraph (A) of this regulation shall become void ab initio with respect to the person who introduced such shipment or delivery into 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 food under clause (2) of paragraph (A) of this regulation shall expire–

1. (1) at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment if the food comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the Act when so removed; or
2. (2) upon refusal by the operator of the establishment where such food is to be processed, labeled, or repacked, to make available for inspection a copy of the agreement, as required by such clause.

(Indiana Department of Health; Reg HFD 6; filed Oct 18, 1945, 10:30 am: Rules and Regs. 1947, p. 1321; readopted filed Jul 11, 2001, 2:23 p.m.: 24 IR 4234; readopted filed May 22, 2007, 1:44 p.m.: 20070613-IR-410070141RFA; readopted filed Sep 11, 2013, 3:19 p.m.: 20131009-IR-410130346RFA; readopted filed Nov 13, 2019, 3:14 p.m.: 20191211-IR-410190391RFA)