General requirements.

(a) General. The test procedures prescribed in this subpart are intended to ensure that Large Packagings containing hazardous materials can withstand normal conditions of transportation. These test procedures are considered minimum requirements. Each packaging must be manufactured and assembled so as to be capable of successfully passing the prescribed tests and to conform to the requirements of § 173.24 of this subchapter while in transportation.

(b) Responsibility. The Large Packaging manufacturer is responsible for ensuring each Large Packaging is capable of passing the prescribed tests. To the extent a Large Packaging's assembly function, including final closure, is performed by the person who offers a hazardous material for transportation, that person is responsible for performing the function in accordance with §§ 173.22 and 178.2 of this subchapter.

(c) Definitions. For the purpose of this subpart:

(1) Large packaging design type refers to a Large Packaging which does not differ in structural design, size, material of construction and packing.

(2) Design qualification testing is the performance of the drop, stacking, and bottom-lift or top-lift tests, as applicable, prescribed in this subpart, for each different Large Packaging design type, at the start of production of that packaging.

(3) Periodic design requalification test is the performance of the applicable tests specified in paragraph (c)(2) of this section on a Large Packaging design type, to requalify the design for continued production at the frequency specified in paragraph (e) of this section.

(4) Production inspection is the inspection, which must initially be conducted on each newly manufactured Large Packaging.

(5) Different Large Packaging design type is one which differs from a previously qualified Large Packaging design type in structural design, size, material of construction, wall thickness, or manner of construction, but does not include:

(i) A packaging which differs in surface treatment;

(ii) A rigid plastic Large Packaging, which differs with regard to additives used to comply with § 178.925(b) or § 178.940(b);

(iii) A packaging which differs only in its lesser external dimensions (i.e., height, width, length) provided materials of construction and material thickness or fabric weight remain the same;

(6) Remanufactured Large Packaging is a metal or rigid Large Packaging that is produced as a UN type from a non-UN type or is converted from one UN design type to another UN design type. Remanufactured Large Packagings are subject to the same requirements of this subchapter that apply to new Large Packagings of the same type.

(7) Reused Large Packaging is a Large Packaging intended to be refilled and has been examined and found free of defects affecting its ability to withstand the performance tests. See also § 173.36(c) of this subchapter.

(d) Design qualification testing. The packaging manufacturer must achieve successful test results for the design qualification testing at the start of production of each new or different Large Packaging design type. Application of the certification mark by the manufacturer constitutes certification that the Large Packaging design type passed the prescribed tests in this subpart.

(e) Periodic design requalification testing. (1) Periodic design requalification must be conducted on each qualified Large Packaging design type if the manufacturer is to maintain authorization for continued production. The Large Packaging manufacturer must achieve successful test results for the periodic design requalification at sufficient frequency to ensure each packaging produced by the manufacturer is capable of passing the design qualification tests. Design requalification tests must be conducted at least once every 24 months.

(2) Changes in the frequency of design requalification testing specified in paragraph (e)(1) of this section are authorized if approved by the Associate Administrator.

(f) Test samples. The manufacturer must conduct the design qualification and periodic tests prescribed in this subpart using random samples of packagings, in the numbers specified in the appropriate test section.

(g) Selective testing. The selective testing of Large Packagings, which differ only in minor respects from a tested type is permitted as described in this section. For air transport, Large Packagings must comply with § 173.27(c)(1) and (c)(2) of this subchapter. Variations are permitted in inner packagings of a tested Large Packaging, without further testing of the package, provided an equivalent level of performance is maintained and the methodology used to determine that the inner packaging, including closure, maintains an equivalent level of performance is documented in writing by the person certifying compliance with this paragraph and retained in accordance with paragraph (l) of this section. Permitted variations are as follows:

(1) Inner packagings of equivalent or smaller size may be used provided—

(i) The inner packagings are of similar design to the tested inner packagings (i.e., shape—round, rectangular, etc.);

(ii) The material of construction of the inner packagings (glass, plastic, metal, etc.) offers resistance to impact and stacking forces equal to or greater than that of the originally tested inner packaging;

(iii) The inner packagings have the same or smaller openings and the closure is of similar design (e.g., screw cap, friction lid, etc.);

(iv) Sufficient additional cushioning material is used to take up void spaces and to prevent significant movement of the inner packagings;

(v) Inner packagings are oriented within the outer packaging in the same manner as in the tested package; and

(vi) The gross mass of the package does not exceed that originally tested.

(2) A lesser number of the tested inner packagings, or of the alternative types of inner packagings identified in paragraph (g)(1) of this section, may be used provided sufficient cushioning is added to fill void space(s) and to prevent significant movement of the inner packagings.

(h) Proof of compliance. In addition to the periodic design requalification testing intervals specified in paragraph (e) of this section, the Associate Administrator, or a designated representative, may at any time require demonstration of compliance by a manufacturer, through testing in accordance with this subpart, to ensure packagings meet the requirements of this subpart. As required by the Associate Administrator, or a designated representative, the manufacturer must either:

(1) Conduct performance tests or have tests conducted by an independent testing facility, in accordance with this subpart; or

(2) Make a sample Large Packaging available to the Associate Administrator, or a designated representative, for testing in accordance with this subpart.

(i) Record retention. Following each design qualification test and each periodic retest on a Large Packaging, a test report must be prepared.

(1) The test report must be maintained at each location where the packaging is manufactured, certified, and a design qualification test or periodic retest is conducted as follows:

Responsible party Duration Person manufacturing the packaging As long as manufactured and two years thereafter. Person performing design testing Design test maintained for a single or composite packaging for six years after the test is successfully performed and for a combination packaging or packaging intended for infectious substances for seven years after the test is successfully performed. Person performing periodic retesting Performance test maintained for a single or composite packaging for one year after the test is successfully performed and for a combination packaging or packaging intended for infectious substances for two years after the test is successfully performed.

(2) The test report must be made available to a user of a Large Packaging or a representative of the Department of Transportation upon request. The test report, at a minimum, must contain the following information:

(i) Name and address of test facility;

(ii) Name and address of applicant (where appropriate);

(iii) A unique test report identification;

(iv) Date of the test report;

(v) Manufacturer of the packaging;

(vi) Description of the packaging design type (e.g., dimensions, materials, closures, thickness, etc.), including methods of manufacture (e.g., blow molding) and which may include drawing(s) and/or photograph(s);

(vii) Maximum capacity;

(viii) Characteristics of test contents, e.g., viscosity and relative density for liquids and particle size for solids;

(ix) Mathematical calculations performed to conduct and document testing (for example, drop height, test capacity, outage requirements, etc.);

(x) Test descriptions and results; and

(xi) Signature with the name and title of signatory.

[75 FR 5400, Feb. 2, 2010, as amended at 75 FR 60339, Sept. 30, 2010; 76 FR 3389, Jan. 19, 2011; 78 FR 14715, Mar. 7, 2013; 78 FR 65487, Oct. 31, 2013]