603-029-1024 Packaging Materials (1) Edible products may not be packaged in a container which is composed in whole or in part of any poisonous or deleterious substances which may render the contents adulterated or injurious to health. All packaging materials must be safe for their intended use within the meaning of section 409 of the Federal Food, Drug, and Cosmetic Act, as amended (FFDCA). (2) Packaging materials entering the state-inspected establishment must be accompanied or covered by a guaranty, or statement of assurance, from the packaging supplier under whose brand name and firm name the material is marketed to the state-inspected establishment. The guaranty shall state that the materials intended use complies with the FFDCA and all applicable food additive regulations. The guaranty must identify the material, e.g., by the distinguishing brand name or code designation appearing on the packaging material shipping container; must specify the applicable conditions of use, including temperature limits and any other pertinent limits specified under the FFDCA and food additive regulations; and must be signed by an authorized official of the supplying firm. The guaranty may be limited to a specific shipment of an article, in which case it may be part of or attached to the invoice covering such shipment, or it may be general and continuing, in which case, in its application to any article or other shipment of an article, it shall be considered to have been given at the date such article was shipped by the person who gives the guaranty. Guaranties consistent with the Food and Drug Administration's regulations regarding such guaranties (21 CFR 7.12 and 7.13) will be acceptable. The management of the state-inspected establishment must maintain a file containing guaranties for all food contact packaging materials in the state-inspected establishment. The file shall be made available to Inspectors or other Department officials upon request. While in the state inspected establishment, the identity of all packaging materials must be traceable to the applicable guaranty. (3) The guaranty by the packaging supplier will be accepted by Department inspectors to establish that the use of material complies with the FFDCA and all applicable food additive regulations. (4) The Department will monitor the use of packaging material in state-inspected establishments to assure that the requirements of section (1) of this rule are met and may question the basis for any guaranty described under section (2) of this rule. state-inspected establishments and packaging suppliers providing written guaranties to those state-inspected establishments will be permitted an opportunity to provide information tm designated Department officials as needed to verify the basis for any such guaranty. The required information will include, but is not limited to, manufacturing firm’s name, trade name or code designation for the material, complete chemical composition, and use. Selection of a material for review does not in itself affect a material’s acceptability. Materials may continue to be used during the review period. However, if information requested from the supplier is not provided within the time indicated in the request—a minimum of 30 days—any applicable guaranty shall cease to be effective, and approval to continue using the specified packaging material in state-inspected establishments may be denied. The Department may extend this time where reasonable grounds for extension are shown, as, for example, where data must be obtained from suppliers. (5) The Department may disapprove for use in state-inspected establishments packaging materials whose use cannot be confirmed as complying with FFDCA and applicable food additive regulations. Before approval to use a packaging material is finally denied by the Department, the affected state-inspected establishment and the supplier of the material shall be given notice and the opportunity to present their views to the Department. If the state-inspected establishment and the supplier do not accept the Department's determination, a hearing in accordance with applicable rules of practice will be held to resolve such dispute. Approval to use the materials pending the outcome of the presentation of views or hearing shall be denied if the Department determines that such use may present an imminent hazard to public health. (6) Periodically, the Department will issue to Inspectors a listing, by distinguishing brand name or code designation, of packaging materials that have been reviewed and that fail to meet the requirements of section (1) of this rule. Listed materials will not be permitted for use in state-inspected establishments. If a subsequent review of any material indicates that it meets the requirements of section (1), the material will be deleted from the listing. (7) Nothing in this rule shall affect the authority of Inspectors to refuse a specific material if he/she determines the material may render products adulterated or injurious to health. Statutory/Other Authority: ORS 603.085, ORS 619.042 & ORS 619.046 Statutes/Other Implemented: ORS 603.085, ORS 619.042 & ORS 619.046 History: DOA 19-2022, adopt filed 07/27/2022, effective 07/28/2022