The IATA Dangerous Goods Regulations ("DGR"), 40^th edition, became effective on January 1, 1999 and reflects some changes in the definition of diagnostic specimens and biological products from the prior year.

Under the 40^th edition, the definition of an Infectious Substance remains the same. It was in the category of diagnostic specimens that the change occurred. Under the new definition, IATA expanded the definition to include human or animal material being shipped "for diagnostic or investigational purposes…"

Here are the new classification rules for Diagnostic Specimens, and Biological Products that are intended for transport aboard IATA member aircraft. These rules went into effect on January 1, 1999.

IATA DGR 3.6.2.4 Classification of Diagnostic Specimens:

For the purposes of these Regulations, diagnostic specimens as defined in 3.6.2.1 are divided into the following groups:

1. those known or reasonably expected to contain pathogens in Risk Groups 2,3, or 4 and those where a relatively low probability exists that pathogens of Risk Group 4 are present. Such substances must be classified in Division 6.2 under UN 2814 or UN 2900 as appropriate. Specimens transported for the purposes of initial or confirmatory testing for the presence of pathogens fall within this group.
2. those where a relatively low probability exists that pathogens of Risk Group 2 or 3 are present. Specimens transported for the purpose of routine screening tests or initial diagnosis for other than the presence of pathogens fall within this group (see Packing Instruction 650).
3. those known not to contain pathogens (not restricted)

The significant change in these classification rules falls into two categories:

1. Under previous rules [in effect before 1999], specimens had to be tested before being classified in category [ c ] above, basically proving that no pathogens existed in the sample. Under the new rules, this testing requirement has been dropped and has been replaced with the condition that " there is no reason to suspect" that the specimen contains pathogens in order to be classified "not restricted".
2. Classification of biological products and diagnostic specimens has been compartmentalized into separate categories. Three (3) new categories have been established for biological products.

3.6.2.1.3 Biological Products (general definition)

These products are derived from living organisms that are manufactured and distributed in accordance with the requirements of national governmental authorities that may have special licensing requirements. The products are used either for prevention, treatment, or diagnosis of disease in humans or animals, or for development, experimental or investigational purposes related thereto. They include, but are not limited to finished or unfinished products such as vaccines and diagnostic products.

DGR 3.6.2.3 Classification of Biological Products (the new rules)

For the purposes of these Regulations, biological products as defined in 3.6.2.1 are divided into the following groups:

1. those which contain pathogens in Risk Group 1: those which contain pathogens under such conditions that their ability to produce disease is very low to none; and those known not to contain pathogens. Substances in this group are not considered infectious substances for the purposes of these Regulations and are not subject to the requirements for Division 6.2.
2. those manufactured and packaged in accordance with the requirements of national governmental health authorities and transported for the purposes of final packaging or distribution, and use for personal health care by medical professionals or individuals. Substances in this group are considered are not subject to the requirements for Division 6.2.
3. those known or reasonably expected to contain pathogens in Risk Groups 2, 3, or 4 and which do not meet the criteria of 3.6.2.3(b) above. Substances in this group must be classified in Division 6.2 under UN 2814 or UN 2900 as appropriate.

 Under this new definition of biological products, only those known to contain an Infectious Substance are restricted. Other biological products are not restricted as to quantity limitations.