178.1035 General requirements.§ 178.1035 General requirements.
(a) General. The test procedures prescribed in this subpart are intended to ensure that Flexible Bulk Containers 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 Flexible Bulk Container manufacturer is responsible for ensuring each Flexible Bulk Containers is capable of passing the prescribed tests. To the extent a Flexible Bulk Container'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) Flexible Bulk Container design type refers to a Flexible Bulk Container that does not differ in structural design, size, material of construction and packing.
(2) Design qualification testing is the performance of the drop, topple, righting, tear, stacking, and top-lift tests prescribed in this subpart, for each different Flexible Bulk Container 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 Flexible Bulk Container 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 that must initially be conducted on each newly manufactured Flexible Bulk Container.
(5) Different Flexible Bulk Container design type is one that differs from a previously qualified Flexible Bulk Container design type in structural design, size, material of construction, wall thickness, or manner of construction, but does not include:
(i) A packaging that differs in surface treatment;
(ii) A packaging that 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;
(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 Flexible Bulk Container design type. Application of the certification mark by the manufacturer constitutes certification that the Flexible Bulk Container design type passed the prescribed tests in this subpart.
(e) Periodic design requalification testing. (1) Periodic design requalification must be conducted on each qualified Flexible Bulk Container design type if the manufacturer is to maintain authorization for continued production. The Flexible Bulk Container 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) 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 Flexible Bulk Container available to the Associate Administrator, or a designated representative, for testing in accordance with this subpart.
(h) Record retention. Following each design qualification test and each periodic retest on a Flexible Bulk Container, a test report must be prepared. The test report must be maintained at each location where the Flexible Bulk Container is manufactured and each location where the design qualification tests are conducted, for as long as the Flexible Bulk Container is produced and for at least two years thereafter, and at each location where the periodic retests are conducted until such tests are successfully performed again and a new test report produced. In addition, a copy of the test report must be maintained by a person certifying compliance with this part. The test report must be made available to a user of a Flexible Bulk Container or a representative of the Department upon request. The test report, at a minimum, must contain the following information:
(1) Name and address of test facility;
(2) Name and address of applicant (where appropriate);
(3) A unique test report identification;
(4) Date of the test report;
(5) Manufacturer of the packaging;
(6) Description of the flexible bulk container 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);
(7) Maximum capacity;
(8) Characteristics of test contents (e.g., particle size for solids);
(9) Mathematical calculations performed to conduct and document testing (e.g., drop height, test capacity, outage requirements, etc.);
(10) Test descriptions and results; and
(11) Signature with the name and title of signatory.