Interpretation Response #99-0137 ([Southcorp Packaging USA, Inc.] [Mr. Stephen E. Danek])

Below is the interpretation response detail and a list of regulations sections applicable to this response.

Interpretation Response Details

Response Publish Date: 07/13/2000

Company Name: Southcorp Packaging USA, Inc.

Individual Name: Mr. Stephen E. Danek

Location State: IN Country: US

View the Interpretation Document

Response text:

July 13, 2000

Mr. Stephen E. Danek                    Ref.  No. 99-0137
Southcorp Packaging USA, Inc.
6047 Guion Road
Indianapolis, IN 46254

Dear Mr. Danek:

This is in response to your letter requesting clarification of selective testing under Variation 5, with regard to testing different closures or gaskets on similar packages, under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180). 1 apologize for the delay in responding and hope it has not caused any inconvenience.  Your questions are paraphrased and answered as follows:

Ql.       Are qualifying tests required for non-removable head UN lH1 or UN 3HI, 5 or 6 gallon capacity plastic packagings, with different threaded non-vented or vented closures?  Can different closure/gasket combinations with a design qualification covering a 5-gallon removable head drum (UN I 1-12) with 70min threaded closures and gaskets, for example, “W and Y”, “X and Z”, “X and Y”, or  “W and Z”, respectively, be used without further testing?

Al.        When a closure device has been qualified by means of the tests referenced in Variation 5, § 178.601 (g)(5), that closure device may be used on any packaging of the same type with at least the same integrity.  If four different closure devices have been qualified through the specified  “qualifying tests,” any one of those closure devices or any combination of those closure devices may be used.  For single packagings ranging in size from 5 to 6 gallons capacity, and provided the only difference between the packagings is the size or capacity, tests run on the packagings with the greatest size or capacity will qualify all packagings with a lesser size or capacity.

Q2.      What does the phrase “provided an equivalent level of performance is maintained”,
            § 178.601(g)(5), mean?

A2.      The phrase “provided an equivalent level of performance is maintained” means that the packaging must be equally effective and the testing method used must be equivalent to that of the tested design type.

Q3.      Are periodic retests required for single packagings (UN 1HI or UN 3HI) installed with different closure devices (e.g., 70mm. threaded vented or non-vented closure devices), or do periodic retests done, for example, on crimp-on-fittings, cover only crimp-on fittings that fit the same neck finish that have previously passed the qualifying tests under Variation “59".

A3.      Single packagings (e.g., UN 11-11 or UN 3111) that differ from a tested design type only to the extent that the closure device or gasketing differs from that used in the originally tested design type, may be used without further testing, provided an equivalent level of performance is maintained, subject to the conditions prescribed under Variation "5".

Q4.      Are closures with only minor differences considered a design change; and when one of these closures is certified, are the others certified as well?  For example, the Rieke FS-70 has a 3/4" diameter threaded recess, the bottom of which can be bored out by the end user for insertion of a faucet; the FS-80 has a flat top surface; and the FS-80T is the same as the FS-80 except that it has a tamper-evident ring with additional plastic (which does not affect the performance of the package) at the base of the neck opening to catch the ring and break it off when the container is initially opened.

A4.      Changes in closures on single packagings are permitted without further design testing under the conditions prescribed in §178.601(g)(5). If the tests required in §178.601(g)(5) have been successfully completed, the new closure system would not be considered a design change.

Q5.      If multiple closures and/or gaskets, having passed the qualifying tests under Variation 5, are certified under a single periodic retest, must the periodic retest report indicate all of the closures and/or gasket combinations that are covered?  Can an archived report showing evidence of previously passed qualifying tests along with a current periodic retest report that only reports the single closure and gasket combination used for the testing be used to prove certification of multiple closures and/or gaskets?

A5.      A test report must be completed for each packaging design qualification test and each periodic retest.  Section 178.601 (1) sets forth the information that must be included in each test report.  A person applying a selective testing variation is not required to make a note of it in the documentation of a tested design type or a periodic retest report.

I hope this satisfies you inquiry.  If we can be of further assistance, please contact us.

Sincerely,

Delmer F. Billings
Chief, Regulations Development
Office of Hazardous Materials Standards

178.601

Regulation Sections