340-090-0340 Exempt Rigid Plastic Containers (1) Rigid plastic containers that meet one of the sets of criteria in sections (2) through (7) of this rule are exempt from the requirements of OAR 340-090-0350 through -0370. (2) The product in the rigid plastic container is one of the following: (a) A "drug" as defined in OAR 340-090-0320(5); (b) A "medical device" as defined in OAR 340-090-0320(9); (c) "Medical food" as defined in OAR 340-090-0320(10); or, (d) "Infant formula" as defined in OAR 340-090-0320(8). (3) The rigid plastic container and product are shipped out of Oregon before they are sold to the final consumer. (4) The packaging is necessary to provide a tamper-resistant seal for public health purposes: (a) For the purposes of OAR 340-090-0310 through 0430, packaging that provides a tamper-resistant seal is one of the following: (A) A separate device associated with a rigid plastic container that resists tampering with the product in the container or exposes when an attempt to tamper with a product has occurred. Such devices include but are not limited to tape, film, foil, and tamper-resistant caps and lids; or (B) A portion of a rigid plastic package that is designed to work with a device described in paragraph (A) of this subsection or which independently resists tampering with the product in the container or exposes when an attempt to tamper with a product has occurred. (b) A complete rigid plastic container may not be considered "necessary to provide a tamper-resistant seal" and may not be exempt under the provisions of this rule. (5) The container is a reduced container: (a) A container is a reduced container when the container/product ratio has been reduced by at least ten percent when compared with the container used for the same product by the same product manufacturer five years earlier: (A) For a container that has been changed to a reduced container after January 1, 1990 and before January 1, 1995: (i) Comparison must be made to the container/product ratio of the equivalent container sold five years earlier; (ii) The exemption must start on January 1, 1995; and must run until January 1, 2000. (B) For a container which has been changed to a reduced container on or after January 1, 1995: (i) Comparison must be made to the container/product ratio of the equivalent container sold five years earlier; (ii) The exemption must start on the date the reduced container was first used by the product manufacturer and must run for five years. (b) A reduction in container/product ratio may not be achieved by substituting plastic for a different material for a substantial part of the container; (A) Different material means a material other than plastic, including but not limited to glass, metal, wood, or paper; (B) Use of different plastic resins or combinations of plastic resins is not use of a different material. (c) For the purposes of calculating the container/product ratio, a unit of product is one of the following: (A) A unit of weight of product; (B) A unit of volume of product; or (C) A unit of product use: (i) To qualify as a "unit of product," a "unit of product use" must be clearly stated on the container or in other product use instructions; (ii) Some examples of units of product use include the number of "standard applications," "servings," or other generally accepted units of product use. (d) A reduced container is not exempt from OAR 340-090-0350 through -0370 if DEQ finds that changes made in the original container adversely impact the potential for the container to be recycled or to contain recycled content; (e) A reduced container is not exempt from OAR 340-090-0350 through -0370 if the container/product ratio for the original container was increased after January 1, 1990; (f) For purposes of receiving an exemption under this section, a concentrated form of a product must be considered to be the "same product by the same product manufacturer" if it: (A) Has the same product line name; and (B) Is intended for the same use. (6)(a) There has been a substantial investment in achieving the recycling rate. To meet the "substantial investment" exemption, all of the following provisions must be met: (A) A substantial investment has been made in achieving the recycling rate; (B) There is a demonstrated viable market for the material from which the container is made; (C) The 1995 recycling rate for compliance purposes is at least 20%; (D) The recycling rates for the rigid plastic containers for the previous two years show evidence of increasing; and (E) Reasonable projections indicate that the rigid plastic containers will meet the 25 percent recycling rate by January 1, 1997. (b) The exemption provided under the provisions of ORS 459A.660(5)(e) must be a one-time exemption with an effective date of January 1, 1995 to December 31, 1996; (c) DEQ must, before January 1, 1995, determine if the conditions for the "substantial investment exemption" for rigid plastic containers, in the aggregate, have been met. (7) The container contains food: (a) A container must be considered to "contain food" if it contains an article used, or intended to be used, for food, ice, confection or condiment, whether simple or compound, or any part or ingredient thereof or in the preparation thereof, and for human consumption. (b) A container may not be considered to "contain food" if it contains a drinkable liquid and is a rigid plastic bottle. Statutory/Other Authority: ORS 459A.025 & 468.020 Statutes/Other Implemented: ORS 459A.660 History: DEQ 3-2017, f. & cert. ef. 1-19-17 DEQ 9-1996, f. & cert. ef. 7-10-96 DEQ 26-1994, f. & cert. ef. 11-2-94