PACKAGING INSTRUCTIONS

Changes in the Packaging Requirements for Diagnostic Specimens

Effective February 14, 2003, diagnostic specimens are no longer exempt from the Department of Transportation (DOT) Hazardous Materials Regulations (HMR) under Docket Number HM-226. HM-226 will bring the United States regulations in line with international regulations. The major change that will affect most shippers is the packaging requirement for diagnostic specimens.

The Department of Transportation’s definition of a diagnostic specimen is "any human or animal material, including excreta, secreta, blood and its components, tissue, and tissue fluids being transported for diagnostic or investigational purposes, but excluding live infected humans or animals."

Some of the major changes are listed below:

• Diagnostic specimens must be packed in a triple packaging, consisting of a primary receptacle, a secondary packaging, and an outer packaging.
• Primary receptacles must be packed in secondary packaging in such a way that, under normal conditions of transport, they cannot break, be punctured, or leak their contents.
• The secondary package must be secured in the outer packaging with suitable cushioning material.
• The completed package must be capable of successfully passing a drop test at a height of at least 1.2 meters (3.9 feet).
• The outer packaging must be clearly marked with the words "Diagnostic Specimen." NOTE: For air shipments: the outer packing must show the text: "DIAGNOSTIC SPECIMEN PACKED IN COMPLIANCE WITH IATA PACKING INSTRUCTION 650".
• For liquid specimens by aircraft, the primary receptacle or the secondary packaging must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa in the range of -40° to +55° (-40°F to 130°F).

Click here for complete packing instructions

There are two types of packaging available from the NIH self-service stores and the NIH Supply Catalog that meet the requirements of IATA Packing Instruction 650. They are: (1) Saf-T-Pak STP 210, National Stock Number 8115-00-L04-0707 and (2) Saf-T-Pak STP 250, National Stock Number 8115-00-L04-0708.Training requirements remain the same. When shipping by air, under IATA regulations, a shipper must be trained every two years and their training must be updated to include any changes brought about by new regulations, such as HM-226.

Companies that offer training seminars:

• http://phmsa.dot.gov/hazmat
• http://www.saftpak.com/
• http://www.highqllc.com/
• http://www.fedex.com/us/services/options/seminars.html
• http://www.cargotraining.com/menu.htm
• http://www.dgitraining.com/menu.htm
• http://cargopak.com/
• http://www.allpakinc.com/

Packing Instructions

[Code of Federal Regulations]
[Title 49, Volume 2]
[Revised as of October 1, 2002]

From the U.S. Government Printing Office via GPO Access [CITE: 49CFR173.199]
[Page 518-520]

TITLE 49--TRANSPORTATION
CHAPTER I—RESEARCH AND SPECIAL PROGRAMS ADMINISTRATION, DEPARTMENT OF TRANSPORTATION

PART 173--SHIPPERS—GENERAL REQUIREMENTS FOR SHIPMENTS AND PACKAGINGS—Table of Contents

Subpart E—Non-bulk Packaging for Hazardous Materials Other Than Class 1 and Class 7

Sec. 173.199 Diagnostic specimens and used health care products.

1. Diagnostic specimens. Except as provided in this paragraph (a), diagnostic specimens are excepted from all other requirements of this subchapter when offered for transportation or transported in accordance with this section. Diagnostic specimens offered for transportation or transported by aircraft under the provisions of this section are subject to the incident reporting requirements in Secs. 171.15 and 171.16 of this subchapter. A diagnostic specimen meeting the definition of a hazard class other than Division 6.2 must be offered for transportation or transported in accordance with applicable requirements of this subchapter.
   1. Diagnostic specimens must be packaged in a triple packaging, consisting of a primary receptacle, a secondary packaging, and an outer packaging.
   2. Primary receptacles must be packed in secondary packaging in such a way that, under normal conditions of transport, they cannot break, be punctured, or leak their contents into the secondary packaging.
   3. Secondary packaging must be secured in outer packaging with suitable cushioning material such that any leakage of the contents will not impair the protective properties of the cushioning material or the outer packaging.
   4. The completed package must be capable of successfully passing the drop test in Sec. 178.603 of this subchapter at a drop height of at least 1.2 meters (3.9 feet). The outer packaging must be clearly and durably marked with the words "Diagnostic Specimen."
2. Liquid diagnostic specimens. Liquid diagnostic specimens must be packaged in conformance with the following provisions:
   1. The primary receptacle must be leak-proof with a volumetric capacity of not more than 500 mL (16.9 ounces).
   2. Absorbent material must be placed between the primary receptacle and secondary packaging. If several fragile primary receptacles are placed in a single secondary packaging, they must be individually wrapped or separated so as to prevent contact between them. The absorbent material must be of sufficient quantity to absorb the entire contents of the primary receptacles.
   3. The secondary packaging must be leak-proof.
   4. For shipments by aircraft, the primary receptacle or the secondary packaging must be capable of withstanding without leakage an internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi).
   5. The outer packaging may not exceed 4 L (1 gallon) capacity.
3. Solid diagnostic specimens. Solid diagnostic specimens must be packaged in a triple packaging, consisting of a primary receptacle, secondary packaging, and outer packaging, conforming to the following provisions:
   1. The primary receptacle must be sift-proof with a capacity of not more than 500 g (1.1 pounds).
   2. If several fragile primary receptacles are placed in a single secondary packaging, they must be individually wrapped or separated so as to prevent contact between them.
   3. The secondary packaging must be leak-proof.
   4. The outer packaging may not exceed 4 kg (8.8 pounds) capacity.
4. Used health care products. A used health care product being returned to the manufacturer or the manufacturer’s designee is excepted from the requirements of this subchapter when offered for transportation or transported in accordance with this section. For purposes of this section, a health care product is used when it has been removed from its original inner packaging. Used health care products contaminated with or suspected of contamination with a Risk Group 4 infectious substance may not be transported under the provisions of this section.
   1. Each used health care product must be drained of free liquid to the extent practicable and placed in a watertight primary container designed and constructed to assure that it remains intact under conditions normally incident to transportation. For a used health care product capable of cutting or penetrating skin or packaging material, the primary container must be capable of retaining the product without puncture of the packaging under normal conditions of transport. Each primary container must be marked with a BIOHAZARD marking conforming to 29 CFR 1910.1030(g)(1)(i).
   2. Each primary container must be placed inside a watertight secondary container designed and constructed to assure that it remains intact under conditions normally incident to transportation. The secondary container must be marked with a BIOHAZARD marking conforming to 29 CFR 1910.1030(g)(1)(i).
   3. The secondary container must be placed inside an outer packaging with sufficient cushioning material to prevent movement between the secondary container and the outer packaging. An itemized list of the contents of the primary container and information concerning possible contamination with a Division 6.2 material, including its possible location on the product, must be placed between the secondary container and the outside packaging.
5. Training. Each person who offers or transports a diagnostic specimen or used health care product under the provisions of this section must know about the requirements of this section.

[67 FR 53240, Aug. 14, 2002]

Effective Date Note: At 67 FR 53140, Aug. 14, 2002, Sec. 173.199 was added, effective Oct. 1, 2002. At 67 FR 54967, Aug. 27, 2002, the effective date was corrected to Feb. 14, 2003.

INTERNATIONAL AIR TRANSPORT ASSOCIATION (IATA)DANGEROUS GOOD REGULATIONS
PACKING INSTRUCTIONS 650

General Requirements:
Diagnostic specimens must be packed in good quality packaging, which must be strong enough to withstand the shocks and loadings normally encountered during transport, including trans-shipment between transport units and warehouses as well as any removal from a pallet or overpack for subsequent manual or mechanical handling. Packaging must be constructed and closed to prevent any loss of contents when prepared for transport which might be caused under normal conditions of transport, by vibration, or by changes in temperature, humidity or pressure.

Primary receptacles must be packed in secondary packaging in such a way that, under normal conditions of transport, they cannot break, be punctured or leak their contents into the secondary packaging. Secondary packaging must be secured in outer packaging with suitable cushioning material. Any leakage of the contents must not substantially impair the protective properties of the cushioning material or of the outer packaging.

Packages must be prepared as follows:

1. For Liquids:
   • The primary receptacle(s) must be leak-proof and must not contain more than 500 ml.
   • There must be absorbent material placed between the primary receptacle and the secondary packaging; if several fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them. The absorbent material, such as cotton wool, must be in sufficient quantity to absorb the entire contents of the primary receptacles and there must be a secondary packaging which must be leak-proof.
   • The primary receptacle or the secondary packaging must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa in the range of -40°C to +55°C (-40°F to 130°F).
   • The outer packaging must not contain more than 4 L.
2. For Solids:
   • The primary receptacle(s) must be sift-proof and must not contain more than 500 g.
   • If several fragile primary receptacles are placed in a single secondary packaging, they must be either individually wrapped or separated to prevent contact between them and there must be a secondary packaging which must be leak-proof.
   • The outer packaging must not contain more than 4 kg.

An itemized list of contents must be enclosed between the secondary packaging and the outer packaging.

Each completed package must be capable of successfully passing the drop test described in 6.5.1 except that the height of the drop must not be less than 1.2m.

Packages consigned as freight must be at least 100 mm (4 in.) in the smallest overall external dimension.

Each package and the "Nature and Quantity of Goods" box of the air waybill must show the text "DIAGNOSTIC SPECIMEN PACKED IN COMPLIANCE WITH IATA PACKING INSTRUCTION 650".

With effect from 1 January 2004, each package must also be marked to indicate that the shipper has determined that the packaging meets the applicable are transport requirements. The marking must include the symbol consisting of an aircraft within a circle and may include the words "Air Eligible". The marking must be applied adjacent to the words "Diagnostic Specimen".

A Shipper’s Declaration for Dangerous Goods is not required.

Provided diagnostic specimens are packed in accordance with this Packing Instruction, no other requirements of these Regulations apply except for the definition in 3.6.2.1.4 and the reporting of dangerous goods accidents and incidents in 9.6.1.

Specific Requirements
Although exceptional cases, (for example, the shipment of whole organs) may require special packaging, the great majority of diagnostic specimens can and must be packaged according to the following guidelines.

Substances shipped at ambient temperatures or higher: Primary receptacles include those of glass, metal or plastic. Positive means of ensuring a leak-proof seal, such as a heat seal, skirted stopper or metal crimp seal must be provided. If screw caps are used these must be reinforced with adhesive tape.

Substances shipped refrigerated or frozen (wet ice, pre-frozen packs, Carbon dioxide, solid (dry ice): Ice, Carbon dioxide, solid (dry ice) or other refrigerant must be placed outside the secondary packaging(s) or alternatively in an overpack with one or more completed packages. Interior support must be provided to secure the secondary packaging(s) or packages in the original position after the ice or Carbon dioxide, solid (dry ice) has been dissipated. If ice is used the packaging must be leak-proof. If Carbon dioxide, solid (dry ice) is used the outer packaging must permit the release of carbon dioxide gas. The primary receptacle must maintain its containment integrity at the temperature of the refrigerant as well as at the temperatures and pressure of air transport to which the receptacle could be subjected of refrigeration were to be lost.

Substances shipped in liquid nitrogen: Plastic capable of withstanding very low temperatures must be used instead of glass receptacles. Secondary packaging must also withstand very low temperatures and in most cases will need to be fitted over individual primary receptacles. If multiple primary receptacles are placed in a single secondary packaging, they must be separated and supported to ensure that contact between them is prevented. Requirements for shipments of liquid nitrogen must also be observed. The primary receptacle must maintain its containment integrity at the temperature of the refrigerant used as well as at the temperatures and pressure of air transport to which the receptacle could be subjected if refrigeration were to be lost.

Lyophilized substances: Primary receptacles must be either flame-sealed glass ampoules or rubber-stoppered glass vials with metal seals.