Oregon Administrative Rules › Chapter 603 - DEPARTMENT OF AGRICULTURE › Division 29 - STATE MEAT INSPECTION PROGRAM › Section 603-029-1024 - Packaging Materials

Current through Register Vol. 63, No. 7, July 1, 2024
(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