June 29, 2004 - ASM Comments on the WFCC Proposal to revise the UN Model Regulations for the Transport Conditions for Shipping Risk Group 2 Organisms

Mr. Olivier Kervella
United Nations Subcommittee of
Experts for the Transport of Dangerous Goods
Room 416
8-14, Avenue de la Paix
CH-1211 Geneva 10
SWITZERLAND

Re: WFCC Proposal to revise the UN Model Regulations for the Transport Conditions for Shipping Risk Group 2 Organisms

Dear Mr. Kervella:

The American Society for Microbiology (ASM) is writing in support of the proposal by the World Federation of Culture Collections (WFCC) to modify United Nations shipping regulations for biological materials classified in Risk Group 2/Category B cultures. The ASM believes that scientific progress and public health will be served by permitting microbial strains in Risk Group 2 to be shipped for the purposes of scientific laboratory work under the same, more reasonable requirements afforded to diagnostic specimens.

The ASM is the largest life science society in the world with a membership of over 42,000. The ASM represents a broad spectrum of subdisciplines, including medical microbiology, applied and environmental microbiology, virology, immunology and molecular biology. The Society's mission is to enhance microbiology worldwide to gain a better understanding of basic life processes and to promote the application of this knowledge for improved health, economic and environmental well-being.

The exchange of scientific information, including microbial strains and cultures, among scientists is essential to progress in all areas of research in microbiology and to address the global burden of infectious diseases. At present, research institutions are experiencing difficulty in moving microbial strains classified as Risk Group 2, although these strains represent negligible risk to public and agricultural safety. Properly and safely packaged and labeled cultures assigned to Risk Group 2 do not have a risk higher than a diagnostic/clinical sample containing infectious substances. Undue restrictions and cost for safe transport of cultures are not justified and may impede critical research efforts.

The ASM, therefore, concurs with the WFCC that the definition of culture according to the UN Model Regulations, 2.6.3.13, should be independent of the purpose of the generation of the culture and whether the culture is transported for diagnostic or investigational purposes or laboratory procedures. A culture of a microorganism assigned to Risk Group 2 should be transported as Category B, UN 3373 (UN Model Regulations 2.6.3.2.2.2). The ASM endorses the following WFCC proposal:

WFCC PROPOSAL

The WFCC PQSR Committee proposes a modification of the UN Model Regulations with respect to classified Risk Group 2 cultures transported for the purposes of scientific laboratory work as follows:

“2.6.3.2.2.2 Category B: An infectious substance which does not meet the criteria for inclusion in Category A. Infectious substances in Category B shall be assigned to UN 3373.

2.6.3.2.2.2.1 Cultures, as defined in 2.6.3.1.3, that contain Category B infectious substances shall be assigned to UN 2814 or UN 2900, as appropriate, except that substances classified for the purposes of laboratory work as Risk Group 2, if they are to be transported, may be offered for transport as Category B, UN 3373.”

We suggest to use the Proper Shipping Name “Infectious substance, Category B” (or vice versa).

The ASM appreciates the opportunity to provide its support for the WFCC proposal to modify UN shipping regulations for Risk Group 2 cultures transported for scientific laboratory work and would be pleased to assist the UN Subcommittee of Experts as it considers this issue.

Sincerely,

Thomas Shenk, Ph.D., President, ASM

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