Ind. Admin. Code tit. 345, r. 9-17-4 – Submission of labels for approval

Sec. 4. (a) Except as otherwise provided in this rule, labels for products to be shipped interstate by an establishment that is a selected establishment under 9 CFR Part 332 must comply with the requirements for participation in the interstate shipment program, such as label approval under 9 CFR Part 317. Except as provided in subsection (f), no label may be used on any product until it has been approved in its final form by the board. For the convenience of the establishment, sketches or proofs of new labels may be submitted in triplicate through the officer in charge to the division for approval and the preparation of finished labels deferred until an approval is obtained. Finished labels must be submitted in triplicate through the officer in charge to the division for approval.

(b) Labels for products containing U.S. origin claims must comply with the following requirements:

(1) The claims "Product of USA" and "Made in the USA" may be approved for use on labels after a finding by the division that the product meets the standards for:
1. (A) single ingredient products set forth in 9 CFR 412.3(a); or
2. (B) multi-ingredient products set forth in 9 CFR 412.3(b)(1).
(2) Claims other than "Product of USA" and "Made in the USA" may be used to designate a qualified U.S. origin claim related to a component of a single or multi-ingredient product's preparation and processing after a finding by the division that the claim:
1. (A) meets the standards set forth in 9 CFR 412.3(c); and
2. (B) is not misbranded.
(3) Claims that designate the state or locality origin of single or multi-ingredient products may be used after a finding by the division that the claim meets the standards set forth in 9 CFR 412.3(d).
(4) Display of the U.S. or state flag, may be used after a finding by the division that the claim meets the standards set forth in 9 CFR 412.3(e).

(c) Establishments choosing to use labels that designate products with U.S. origin claims shall maintain records to support the claim. The division may request access to these records to verify compliance with:

(1) 9 CFR 412.2(f) for a claim of "Product of USA" or "Made in the USA"; or
(2) 9 CFR 412.2(g) for a qualified U.S. origin claim.

(d) If labels are lithographed, paper take-offs instead of sections of the metal containers must be submitted for approval. The paper take-offs must be in the form of a negative, but a complete reproduction of the label as it will appear on the package, including any color scheme involved. For fiber containers, printed layers, such as the kraft paper sheet, must be submitted for approval instead of the complete container.

(e) Inserts, tags, liners, pasters, and like devices containing printed or graphic matter and for use on, or to be placed in, containers and coverings of products must be submitted for approval in the same manner as provided for labels in subsection (a), but officers in charge may permit using those devices that do not contain references to product nor bear misleading features.

(f) Stencils, labels, box dies, and brands may be used on shipping containers and immediate containers, such as tierces, barrels, drums, boxes, crates, and large-sized fiberboard containers, provided the markings are as follows:

(1) Applicable to the product.
(2) Not false or deceptive.
(3) Used with the approval of the officer in charge.

The inspection legend for use in combination with these markings must be approved by the board.

(Indiana State Board of Animal Health; Reg HMP-1R, CH A, PT 18, Sec 19-4; filed Feb 11, 1972, 2:00 p.m.: Rules and Regs. 1973, p. 313; filed Aug 13, 1973, 9:20 a.m.: Rules and Regs. 1974, p. 238; filed Jan 8, 1982, 10:42 a.m.: 5 IR 362; filed Dec 10, 1997, 11:30 a.m.: 21 IR 1307; readopted filed May 2, 2001, 1:45 p.m.: 24 IR 2895; readopted filed May 9, 2007, 3:16 p.m.: 20070516-IR-345070037RFA; readopted filed Aug 7, 2013, 8:32 a.m.: 20130904-IR-345130236RFA; filed Mar 25, 2014, 10:18 a.m.: 20140423-IR-345130230FRA; readopted filed Jul 14, 2020, 1:42 p.m.: 20200812-IR-345200230RFA; filed Aug 14, 2025, 10:14 a.m.: 20250910-IR-345250165FRA) NOTE: Transferred from the Indiana State Department of Health (410 IAC 9-17-4) to the Indiana State Board of Animal Health (345 IAC 9-17-4) by P.L.137-1996, SECTION 76, effective July 1, 1996.