Or. Admin. Code § 340-090-0400 - Responsibilities of a Product Manufacturer
(1)
(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 or with one of the
exemptions set out in OAR
340-090-0340;
(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 must include, at a
minimum, the following information:
(a)
Recycled content. For each container which is complies with OAR
340-090-0350(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(1)(b)(A);
(c) Other recycling rates. For containers
that comply with the specified type container recycling rate requirement, OAR
340-090-0350(1)(b)(B)
or the product-associated container recycling rate requirement, OAR
340-090-0050(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(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(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 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
(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(3);
(c) Reduced containers. For containers that
are exempt under the provisions of OAR
340-090-0340(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(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(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(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)
(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 or exemption under
the provisions of OAR
340-090-0340 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.
Notes
Stat. Auth.: ORS 459A.025 & 468.020
Stats. Implemented: ORS 459A.65 & 459A.660
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