Interpretation Response #02-0264 ([First Filtration International Co., Ltd.] [Alastair Hayton-Williams])

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

Interpretation Response Details

Response Publish Date: 02/13/2003

Company Name: First Filtration International Co., Ltd.

Individual Name: Alastair Hayton-Williams

Country: TH

View the Interpretation Document

Response text:

Feb 13, 2003

Mr. Alastair Hayton-Williams                    Reference No. 02-0264

Sales and Marketing Consultant

First Filtration International Co., Ltd.

37/2 Moo 9, Sukhumvit Road

Banglamung, Chonburi

20260 Thailand

Dear Mr. Hayton-Williams:

This is in response to your letters and additional information concerning your product, the Aqui-Pak pouch.  You described the product as being made of a multi-layered, absorbent, disposable polymeric material. You state that the pouch provides separation, absorption and cushioning in one product and can be used as the secondary packaging for liquid primary receptacles.  You also state that a liquid upon contact with the polymeric material is completely absorbed and becomes a gel.  We have paraphrased your questions.  We apologize for the delay in responding and any inconvenience this may have caused.

Q1. Must our Aqui-Pak pouch be tested by the Research and Special Programs Administration (RSPA) or other company to be approved as a packaging component for a diagnostic specimen under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180)?

A1. The answer is no.  The secondary packaging is not required to be tested as an individual component but as part of the complete packaging.  RSPA does not test or certify hazardous materials packagings.

In a recently published final rule, we adopted new § 173.199 to the HMR to permit a diagnostic specimen other than Risk Group 4 to be transported in a non-DOT specification triple packaging consisting of a primary receptacle, a secondary packaging, and an outer packaging (Docket No. RSPA-98-3971 (HM-226), August 14, 2002, copy enclosed).  This section requires that the primary receptacle and the secondary packaging be properly packed and secured and that the secondary packaging be leakproof.  The completed packaging must also be capable of passing a 1.2 meter (3.9 feet) drop test as prescribed in § 178.603. If intended for the transport of liquids by aircraft, § 173.199(b)(4) requires that the primary receptacle or secondary packaging be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi).  It is the shipper's responsibility to ensure that the packaging or container is an authorized packaging and meets all applicable requirements. A Risk Group 4 diagnostic specimen must be classed and transported as a UN 2814 or UN 2900 infectious substance in a packaging tested and marked as required by § 173.196 and § 178.503(f), respectively.  See §173.134(a)(4). The new requirements become effective February 14, 2003; however, voluntary compliance is authorized.

Q2. Our Aqui-Pak pouch conforms to Packing Instruction 650 of the International Civil Aviation Organization's Technical Instructions for the Transport of Dangerous Goods by Air (ICAO Technical Instructions). Specifically, four samples can be placed alongside each other while allowing each to be in its own absorbent pouch. As such, do we need to take any further steps to qualify our material as an authorized non-bulk secondary packaging?

A2. If, as you state, the combination packaging containing the Aqui-Pak pouch conforms to Packing Instruction 650 of the ICAO Technical Instructions, the answer is no.  However, the completed secondary packaging must meet all applicable requirements.

I hope this satisfies your request.

Sincerely,

Hattie L. Mitchell, Chief

Regulatory Review and Reinvention

Office of Hazardous Materials Regulation

Enclosures

173.199

Regulation Sections