§178.2. Applicability and responsibility. — Inbound Citations

(i) Except for the marking on the bottom of a metal or plastic drum with a capacity over 100 L which has been reconditioned, remanufactured or otherwise converted, the manufacturer's certification, specification, approval, or exemption or special permit marking (see §§ 178.2 and 179.1 of this subchapter); or

(2) Except as otherwise provided in this subchapter, a closure (including gaskets or other closure components, if any) used on a specification packaging must conform to all applicable requirements of the specification and must be closed in accordance with information, as applicable, provided by the manufacturer's notification required by § 178.2 of this subchapter.

(b) 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) Each Specification 7A packaging must comply with the requirements of §§ 178.2 and 178.3. In § 178.3(a)(2) the term “packaging manufacturer” means the person certifying that the package meets all requirements of this section.

(b) It is the responsibility of the packaging manufacturer to assure that each package is capable of passing the prescribed tests. To the extent that a package 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.

(b) It is the responsibility of the IBC manufacturer to assure that each IBC is capable of passing the prescribed tests. To the extent that an IBC 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.

(b) 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.

(a) Any repair or rebuilding of a DOT-4 series cylinder must be performed by a person holding an approval as specified in § 107.805 of this chapter or by a registered facility in Canada in accordance with the Transport Canada TDG Regulations (IBR, see § 171.7 of this subchapter). A person performing a rebuild function is considered a manufacturer subject to the requirements of § 178.2(a)(2) and subpart C of part 178 of this subchapter. The person performing a repair, rebuild, or reheat treatment must record the test results as specified in § 180.215. Each cylinder that is successfully repaired or rebuilt must be marked in accordance with § 180.213.

Each container must be marked as prescribed in § 178.2(b).

(b) Except as provided in § 173.134(c) of this subpart, non-bulk packagings for regulated medical waste or clinical waste or (bio) medical waste must be UN standard packagings conforming to the requirements of part 178 of this subchapter at the Packing Group II performance level. A non-bulk packaging used as a sharps container must be puncture-resistant for sharps and sharps with residual fluid as demonstrated by conducting the performance tests in part 178, subpart M, of this subchapter on packagings containing materials representative of the sharps and fluids (such as sterile sharps) intended to be transported in the packagings. Sharps containers must be securely closed to prevent leaks or punctures in conformance with the instructions provided by the packaging manufacturer in accordance with § 178.2(c) of this subchapter.

(ii) For other than a bulk package or a cylinder, a person must retain a copy of the manufacturer's notification, including closure instructions (see § 178.2(c) of this subchapter). For a bulk package or a cylinder, a person must retain a copy of the manufacturer's notification, including closure instructions (see § 178.2(c) of this subchapter), unless permanently embossed or printed on the package. A copy of the manufacturer's notification, including closure instructions (see § 178.2(c) of this subchapter), unless permanently embossed or printed on the package when applicable, must be made available for inspection by a representative of the Department upon request for at least 90 days once the package is offered to the initial carrier for transportation in commerce. Subsequent offerors of a filled and otherwise properly prepared unaltered package are not required to maintain manufacturer notification (including closure instructions).