05 Dec2015 Regulatory Updates for Shipping Infectious Substances


Published in Advance For Laboratory, Vol. 24 • Issue 1 • Page 23: http://laboratory-manager.advanceweb.com/2015-regulatory-updates-for-shipping-infectious-substances-15419/

By David Creighton is the regulatory and training manager at Saf-T-Pak.

 

Specimen Transport

The regulations for the transport of dangerous goods are updated on a regular basis to ensure they incorporate any new dangerous goods and respond to recent accidents or incidents. Due to numerous changes in the regulations each year both internationally and nationally, shippers are required to be retrained on a regular basis to ensure they are familiar with, and using, the most current version of the regulations.

It is important that all training covers all of the regulatory changes for both national and international regulations. Many changes are harmonized between the numerous organizations, but occasionally there will be differences. The regulatory updates for 2015 contain examples of harmony and disharmony between U.S. and international regulations for the transport of dangerous goods by air, particularly related to infectious substances and related materials.

January 2015 Updates

The air transport of dangerous goods (including infectious substances) is governed globally by the International Civil Aviation Organization (ICAO). The ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air (Technical Instructions, or ICAO TI) are based on the Model Regulations published by the United Nations Subcommittee of Experts (UNSCoE). These Model Regulations are updated every two years and become effective on January 1st of the update year (Jan. 1, 2015 is the most recent). ICAO follows the same protocol, and their updated Technical Instructions also become effective Jan. 1, 2015.

Although these international updates are harmonious throughout most of the world, the United States offers considerable flexibility regarding regulatory updates. For example, the Pipeline and Hazardous Materials Safety Administration (PHMSA), a branch of the Department of Transportation, oversees the updates to the regulations found in Title 49 of the Code of Federal Regulations (49 CFR). To provide sufficient time for printing, PHMSA publishes their regulations with October 1st as the effective date. Although this allows three months lead time to print new editions of the regulations by January 1st, it has caused some confusion regarding timing discrepancies between the U.S. and international regulatory updates, and this has resulted in a number of complaints. To address these concerns, PHMSA plans to release a regulatory update specifically intended to harmonize with international regulatory changes, and to coincide with the international regulatory release date. Now, for the most part, the January 1 update will be used by UNSCoE, ICAO and PHMSA in the U.S., unless the U.S. agency disagrees with an international regulatory update.

Harmony Example

A prime example of this harmonization is the new marking requirement for overpacks. An overpack is an enclosure used to consolidate two or more fully compliant DG packages, or used to provide refrigeration, protection or convenience to a DG package or packages. When the marks and labels on the inside of the overpack are not visible on the outside of the overpack, the marks and labels must be reproduced on the outside of the package. When these marks and labels are reproduced, the term “Overpack” must also be marked on the outside of the package. The topic of mandating a size requirement for the term overpack was discussed by the UNSCoE, resulting in the decision that, effective Jan. 1, 2015, the word “Overpack” must be at least 12 mm in height when marked on an overpack. ICAO adopted the same standard, adding it to the 2015 edition of their Technical Instructions. After reviewing this update, PHMSA agreed with the international regulatory community, and the 49 CFR will incorporate a similar update on the same day. This harmonization allows for the easy transport of overpacks, both nationally and internationally, and will minimize confusion and possible package rejection by an IATA carrier. Packages that exhibit the overpack marking less than 12 mm in height will be permitted until Dec. 31, 2016, after which they will be rejected.

Disharmony Example

An example of disharmony between the U.S. and international regulations was a new exception for used medical devices that was ðintroduced by UNSCoE and ICAO in 2013. A similar exception already existed in the U.S. 49 CFR and was used as a guideline for the UNSCoE and ICAO, but there were distinct differences between the two different regulations.

For example, the international regulations required the package to be capable of passing a 1.2 m drop test and the package must successfully retain the medical device after the drop is performed. However, the 49 CFR regulation for used medical device packaging does not require a drop test. Concern was expressed about subjecting these large and expensive medical devices to a drop test that could damage the equipment. Consequently, ICAO’s 2015 updates allow for different methods of determining drop test capability. ICAO determined that the drop test can be performed by using a sample package that has been prepared for transport, or by using alternative methods, such as non-destructive testing and engineering analysis, testing an article of similar mass and size or other equivalent means. In addition, they added a provision that, before the device is placed in a leakproof liner, it must be drained of any free liquid to the extent practicable.

PHMSA, however, does not agree with UNSCoE and ICAO’s drop test requirement, so the 49 CFR update for Jan. 1, 2015, does not contain the same provision for the testing of used medical device packages. And since the original version of the U.S. regulations for used medical devices already contained the requirement to drain the device of any liquid, it did not need to add this requirement as a regulatory update.

The examples cited represent the major changes to the 2015 transport regulations as they affect shipments of infectious and biological substances and offer excellent examples of the efforts being made to harmonize regulations by the international and U.S. regulatory bodies. Although a regulation may be updated internationally, PHMSA will continue to address these updates on an individual basis. It’s important to recognize the need to receive recurrent training on a regular basis to ensure that these differences are detected and implemented in your organization so packages are shipped in a timely manner, without rejection, no matter the destination.

 


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