Specimen Transport
Regulation Update
By Eric Cook
The regulations governing the transport of infectious and biohazardous material have developed over many years. Particularly in the past several years, with the advent of the AIDS pandemic and increasing international travel, regulators have endeavored to develop a coherent, safe and harmonized system. To accomplish this, most nations, including the United States, and transportation organizations such as the International Air Transport Association (IATA), follow the lead of the United Nations Committee of Experts (UNCOE) in developing their own regulations. These regulations are periodically reviewed and updated.
Background
In the United States, shippers of biohazardous material must comply with the Hazardous Materials Regulations (HMR) developed by the U.S. Department of Transportation (DOT). Research and Special Programs Administration (RSPA) is the department within the DOT that is responsible for developing the HMR. The HMR can be found in Parts 100 to 185 of title 49 of the Code of Federal Regulations (49 CFR).
In addition to the HMR, IATA regulates shipments that pass through the air or go by an air carrier such as FedEx.
IATA is the trade association of the world’s major airlines. Air carriers have a great concern with the transport of dangerous goods and play a major role in the development of the dangerous goods regulations. IATA, like the DOT, bases its regulations on the UNCOE recommendations with a few added restrictions pertinent to air transport and publishes them in the IATA Dangerous Goods Regulations (IATA DGR).
In developing the DGR, IATA has given special attention to the format and wording in order to create an understandable, easy-to-use manual. By following the DGR, shippers of infectious substances will fully comply with the 49 CFR and most other international requirements.
These regulations are updated frequently. IATA produces a new edition of the DGR every year. On January 1, 1999 the 40th edition became effective, superseding 1998’s 39th edition. After consultation with experts in the field and public comment, RSPA also periodically makes changes to the HMR. These are published as final rules in the Federal Register and an effective date is usually attached. The Government Printing Office compiles all the changes and produces a new revision of 49 CFR every October. Access to the most current version of 49 CFR can be found online through http://www.saftpak.com/cfrs.htm.
IATA Changes
The first responsibility of a shipper is to determine whether the material being shipped is a dangerous good or not. The regulations outline specifically the criteria for making this determination. They provide specific definitions for infectious substances, diagnostic specimens and biological products. The definition of infectious substance remains the same. Briefly, these are substances known or reasonably expected to contain pathogens. The definition of a diagnostic specimen has changed slightly. Previous editions limited a diagnostic specimen to human or animal material “being shipped for purposes of diagnosis. . .” This year, IATA broadened the definition slightly to include human or animal material “being transported for diagnostic or investigational purposes, . . .”
Diagnostic specimens as defined above are further classified into three categories.
3.6.2.4 Classification of Diagnostic Specimens
For the purposes of these Regulations, diagnostic specimens as defined in 3.6.2.1.4 are divided into the following groups:
(a) 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.
(b) 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).
(c) those known not to contain pathogens (not restricted).1
Although the classification criteria for diagnostic specimens outlined above is the same in the 40th edition, previous editions of the DGR required samples be tested to confirm the absences of pathogens before consideration for category (c). In the new edition, the testing requirement has been dropped and now there must be “no reason” to suspect a pathogen if one wishes to transport a specimen as not restricted. (Note: Diagnostic specimens should only be regarded as in (c) above if there is no reason to suspect a pathogen in Risk Group 2, 3 or 4 is present.)
Another big change to the DGR that should make things clearer to shippers of biological products, such as vaccines and finished blood products, is that the categories outlined above no longer apply to biological products. Classification of biological products and diagnostic specimens has been separated, and three new categories have been developed for biological products.
3.6.2.3 Classification of Biological Products
For the purposes of these Regulations, biological products as defined in 3.6.2.1.3 are divided into the following groups:
(a) 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.
(b) 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 not considered infectious substances for the purposes of these Regulations and are not subject to the requirements for Division 6.2.
(c) 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.1
With these changes, only biological substances that are known or reasonably expected to contain pathogens become restricted. The rest, if they meet the definition of a “biological product,” are not restricted. As a result, the quantity restrictions of the past and IATA Packing Instruction 650 no longer apply to these materials.
3.6.2.1.3 Biological Products
These are those products derived from living organisms that are manufactured and distributed in accordance with the requirements of national governmental authorities that may have special licensing requirements. They 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.1
These are the major changes. There are a few additional minor ones, most of which are small wording changes that help to further clarify existing regulations and operator variations. Most air carriers in the United States are IATA members and stick to IATA regulations. Therefore, most shippers of biohazardous materials should be already be familiar with and follow IATA standards for transporting hazardous materials. Beyond the IATA regulations, all shippers of biohazardous materials in the United States should be familiar with the hazardous materials transport laws of the DOT.
Future Changes in the United States
It has always been somewhat of a struggle to keep U.S. transportation regulations in harmony with international shipping requirements. While there have been a number of significant changes in the international and air transportation standards with regards to biohazardous materials, the U.S. hazardous materials regulations for these substances have lagged behind. This has led to a few significant differences. A good example is in the way that diagnostic specimens are handled. 49 CFR 173.134(b) provides an exception for these substances. With this exception, diagnostic specimens are not subject to any requirements of the HMR. On the other hand, the IATA DGR requires that certain diagnostic specimens be classified as Class 6.2 dangerous goods and be subject to all applicable requirements. There is even a packing instruction and quantity restrictions for the “non-dangerous” diagnostic specimens (see Classification of Diagnostic Specimens above).
49 CFR 171.11 authorizes use of the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO TI), which is basically identical in content to the IATA DGR, but does not make complying with them a requirement. As a result, many shipments of diagnostic specimens are not properly identified and lack adequate hazard communication. In some instances, packaging for diagnostic specimens lacks sufficient integrity to survive normal handling in transportation causing costly delays and posing risks to cargo handlers, flight crews, emergency responders and others who may have been exposed to infectious substances.
To ensure an acceptable level of safety in the transport of infectious substances, facilitate international transportation and make it easier to understand and comply with the regulations, RSPA is considering revising its standards. RSPA released an Advanced Notice for Proposed Rulemaking (ANPRM) and held an electronic public meeting via the Internet to discuss this proposal. RSPA also solicited input from all parties concerned. RSPA is in the process of reviewing all the information and comments and will shortly release a Notice of Proposed Rulemaking (NPRM). Once this is complete, RSPA will solicit further public comment before making a final revision and publishing the changes as a Final Rule in the Federal Register.
To ensure that diagnostic specimens are regulated consistently with the degree of risk posed by the material, RSPA is considering differentiating between a diagnostic specimen known or reasonably expected to contain a pathogen, from those transported for routine screening or diagnosis for other than the presence of a pathogen. Those in the first group would be considered fully regulated infectious substances and those in the second, although not considered dangerous goods, would still be subject to reduced packaging and hazard communication requirements consistent with current IATA provisions.
Also consistent with IATA, RSPA is considering limiting the broad exception for all biological products to just those that are licensed by the FDA or USDA. Biological products known to contain pathogens would be treated as infectious substances.
Shipments of Genetically Modified Organisms and Micro-Organisms (GMOs) are also affected by the proposed changes. Most international shipping regulations treat any genetically modified material that is known or reasonably expected to cause disease as an infectious substance. In addition, a GMO that does not meet the definition for an infectious substance but is still capable of altering animals, plants or microbiological substances in a way not normally the result of natural reproduction, must be classified as a Class 9 Miscellaneous dangerous good. RSPA is considering whether to align the HMR with the international provisions for GMOs.
RSPA is also considering several changes to the Regulated Medical Waste (RMW) transport provisions, including packaging standards, hazard communication and quantity limits. Finally, RSPA is considering whether to adopt a materials of trade exception for certain biological products, diagnostic specimens and RMW. Entities such as home health care, hospitals and diagnostic laboratories that transport smaller amounts of infectious substances locally in direct support of a principal business other than transportation would benefit.
For shippers of biohazardous materials who are familiar with and comply with the IATA regulations, the changes proposed by RSPA are nothing new and should not affect their business much. However, there are many who have operated under the exceptions provided for diagnostic specimens in the HMR that may be required to make big changes in the coming year. Most companies and individuals in the United States involved in the transport of diagnostic specimens will be affected in some way, and knowledge and training are the key to preparing for what is to come.
For those who wish to take part in developing the HMR, RSPA is always open to public comment. For further information, contact Eileen Mack, Office of Hazardous Materials Standards, (202) 366-8533.
Eric Cook is a biological technical specialist at Saf-T-Pak Inc., Edmonton, Alberta, Canada.
Reference
The International Air Transport Association. Dangerous Goods Regulations 40th Edition Sept. 1998 Montreal—Geneva.
