OAR 340-090-0400
Responsibilities of a Product Manufacturer
(1)
Intentionally left blank —Ed.(a)
A product manufacturer must be able to document that a rigid plastic container or containers comply with either the requirements of OAR 340-090-0350 (Compliance Standards) or with one of the exemptions set out in OAR 340-090-0340 (Exempt Rigid Plastic Containers);(b)
For any calendar year for which DEQ determines that the aggregate recycling rate for compliance purposes is at least 25 percent, a product manufacturer is not required to keep the records otherwise required by this rule.(2)
A product manufacturer’s documentation that a rigid plastic container or containers comply with the provisions of OAR 340-090-0350 (Compliance Standards) must include, at a minimum, the following information:(a)
Recycled content. For each container which is complies with OAR 340-090-0350 (Compliance Standards)(1)(a):(A)
A description of the container, including its resin type, and product; and(B)
A copy of the container manufacturer’s Certificate of Compliance from each manufacturer who supplied that container.(b)
Aggregate recycling rate. The aggregate recycling rate for compliance purposes DEQ establishes must serve as the only acceptable documentation that a product manufacturer’s containers comply with OAR 340-090-0350 (Compliance Standards)(1)(b)(A);(c)
Other recycling rates. For containers that comply with the specified type container recycling rate requirement, OAR 340-090-0350 (Compliance Standards)(1)(b)(B) or the product-associated container recycling rate requirement, OAR 340-090-0050 (Wasteshed Designation and Recovery Rates)(1)(b)(C):(A)
A description of the container and product;(B)
Identification of the specified-type or product-associated criteria;(C)
Documentation of the recycling rate for the type of container pursuant to OAR 340-090-0380 (Recycling Rate Calculation)(4) or (5);(D)
Where DEQ or the container manufacturer has calculated a recycling rate for a specified type or product-associated rigid plastic container, the product manufacturer may rely upon that rate to show that the container complies with the recycling rate requirements.(d)
Reuse and refill. For containers which comply with the reuse requirements, OAR 340-090-0350 (Compliance Standards)(1)(c):(A)
A description of the container and product; and(B)
Documentation of the number of times the containers are refilled or reused:(i)
The number of times a refillable container is reused is determined by review of the product manufacturer’s records which show the following information for a uniform period of time:(I)
The number of returned containers actually refilled;(II)
The number of new containers added to the total number of containers used in the product manufacturer’s refillable container program; and(III)
The total number of containers filled as first-use containers.(ii)
The number of times a reusable container is reused is determined by review of the product manufacturer’s records which show the following information for a uniform period of time:(I)
The amount of product sold in the original container or the number of original containers sold; and(II)
The amount of replacement product sold or the number of refill units of replacement product sold.(iii)
A container must be considered to be used at least five times if it is part of a refillable system or reusable container system which has an average refill or reuse rate for that container of at least four.(3)
A product manufacturer’s records that document that a rigid plastic container or containers are exempt from the requirements of OAR 340-090-0350 (Compliance Standards) through -0370 must include the following information:(a)
Drugs, medical devices, medical food, and infant formula. For containers which are exempt under the provisions of OAR 340-090-0340 (Exempt Rigid Plastic Containers) (2):(A)
A description that clearly identifies the container;(B)
An identification of which of the four product types will be placed in the container;(C)
For drugs:(i)
An FDA letter of approval;(ii)
Documentation of consistency between the over-the-counter drug claims and FDA requirements, (e.g., appropriate references to the FDA Final Monograph or Tentative Final Monograph under which the drug is marketed); or(iii)
Other definitive evidence that the product meets the FDA definition of a drug.(D)
For medical devices: Documentation that the device is intended to be used for diagnosis, cure, or prevention of disease or other definitive evidence that the product meets the FDA definition of a medical device under the FD&C Act (21 U.S.C. 321 (h) and following).(E)
For medical food:(i)
Documentation that the product meets the definition of medical food as defined in the FD&C Act, 1988, and is intended to be used as a medical food;(ii)
Other definitive evidence that the product meets the FDA definition of medical food; or(iii)
Documentation that the product may be labeled “may be used as the sole source of nutrition” or “may be used as the sole item of the diet.”(F)
For infant formula:(i)
Documentation that the product meets the definition of infant formula as set forth in the FD&C Act and is being sold for use as infant formula; or(ii)
Other definitive evidence that the product meets the FDA definition of infant formula.(b)
Shipment out of Oregon. No documentation is required for containers that are exempt under the provisions of OAR 340-090-0340 (Exempt Rigid Plastic Containers)(3);(c)
Reduced containers. For containers that are exempt under the provisions of OAR 340-090-0340 (Exempt Rigid Plastic Containers)(5):(A)
Descriptions, including container resin type, which clearly identify:(i)
The original container before reduction; and(ii)
The reduced container.(B)
An identification of the “unit of product” pursuant to OAR 340-090-0340 (Exempt Rigid Plastic Containers)(5)(c) being used to develop the container/product ratio;(C)
A statement of the container/product ratio and description of how it was calculated for:(i)
The original container before reduction; and(ii)
The reduced container.(d)
Substantial Investment. For containers that are exempt under the provisions of OAR 340-090-0340 (Exempt Rigid Plastic Containers)(6):(A)
Identification of the class of containers and the type of recycling rate for which the exemption is being claimed;(B)
Documentation of the following:(i)
A substantial investment has been made in achieving the recycling rate;(ii)
There is a demonstrated viable market for the material from which the container is made;(iii)
The 1995 recycling rate for compliance purposes is at least 20%;(iv)
The recycling rates for the rigid plastic containers for the previous two years show evidence of increasing; and(v)
Reasonable projections indicate that the rigid plastic containers will meet the 25 percent recycling rate by January 1, 1997.(C)
A product manufacturer may rely upon DEQ’s determination of compliance with the requirements of this exemption for rigid plastic containers in the aggregate or for rigid plastic containers of specified resin type.(e)
Food containers. For containers that are exempt under the provisions of OAR 340-090-0340 (Exempt Rigid Plastic Containers)(7):(A)
Documentation that the container 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 is for human consumption; and(B)
If the container is a rigid plastic bottle, documentation that the container does not contain a drinkable liquid.(4)
Product Manufacturer’s Report of Compliance:(a)
Upon DEQ’s request, a product manufacturer must make a Report of Compliance available to DEQ;(b)
A product manufacturer’s Report of Compliance must be submitted on forms DEQ provides and must contain the following specific information:(A)
The product manufacturer’s:(i)
Name;(ii)
Address; and(iii)
Name, title, address and phone number of an official company representative.(B)
A description of the container for which compliance or exemption is claimed; and(C)
A description of the product manufacturer’s records documenting compliance or exemption.(c)
A product manufacturer must comply with the following procedure and time schedule when it provides information DEQ requests:(A)
The product manufacturer must provide a Report of Compliance to DEQ within 60 days of the date of receipt of a DEQ request for the report;(B)
If DEQ finds the Report to be incomplete, DEQ may request the missing materials from the official company representative. The product manufacturer must provide missing materials from a Report of Compliance to DEQ within 30 days of the date of receipt of a DEQ request for the missing materials;(C)
After it has reviewed the Report of Compliance, DEQ may request that the product manufacturer provide all or part of the documentation described in a Report of Compliance, other records, additional information kept by the product manufacturer which is the basis for those records or any other information deemed necessary to determine compliance with the law. The product manufacturer must provide the records or other material requested to DEQ within 45 days of the date of receipt of a DEQ request for the records.(5)
Intentionally left blank —Ed.(a)
A product manufacturer may request an extension of the time period to submit materials DEQ requests. Such a request for extension must be in writing and received by DEQ prior to the due date of the original DEQ request. The request for extension must:(A)
Provide the product manufacturer’s name and address;(B)
Provide the name, title, address, and phone number of an official company representative;(C)
State a specific length for the requested extension, not to exceed 60 days; and(D)
Show good reason for the extension.(b)
Based upon the information provided in the request for extension, DEQ may grant the extension, deny the extension or grant an extension for a lesser period of time.(6)
Records that document compliance with the requirements of OAR 340-090-0350 (Compliance Standards) or exemption under the provisions of OAR 340-090-0340 (Exempt Rigid Plastic Containers) must be maintained and available for audit by DEQ for a period of at least three years after the year for which compliance is documented.(7)
The Report of Compliance for a product manufacturer that can demonstrate that it sells less than 500 rigid plastic containers per day must consist of the quantity, brand name, product number, if any, and source of purchase of rigid plastic containers. These small product manufacturers are not required to keep other records of container compliance.(8)
DEQ shall consider a product manufacturer’s failure to provide a Report of Compliance or additional materials DEQ requests within the schedule set out in this rule a violation of these rules.
Source:
Rule 340-090-0400 — Responsibilities of a Product Manufacturer, https://secure.sos.state.or.us/oard/view.action?ruleNumber=340-090-0400.