Dockets Management Systems
U.S. Department of Transportation
Room PL-401 400 Seventh Street, SW
Washington, D.C. 20590-0001

RE: RSPA-98-3971 [HM-226]

April 18, 2001

Dear Sirs;
The American Biological Safety Association (ABSA) is an international group of biological safety professionals which is known as one of the world's foremost resources on biological safety practices. We have reviewed the proposed rule, "Hazardous Materials: Revision to Standards for Infectious substances and Genetically Modified Microorganisms" which was published in the January 22, 2001 issue of the Federal Register. We ask that the Research and Special Projects Administration (RSPA) of the U.S. Department of Transportation (DOT) to consider the following comments:

General Comments
The proposal demonstrates a good, workable regulation in this area. It represents a credible effort to harmonize these DOT requirements for the Untied States with the international requirements. We are grateful for your citation of the ABSA web site (http://www.absa.org) as a source of technical information about the risk group criteria of the World Health Organization specifically used in the proposal. Our office has received requests from shippers regarding access to the risk group information on the ABSA web site since your proposal was published.

171.15 - Infectious Substances Definition and Incident Reporting
ABSA commends the move to harmonize the DOT definition for infectious substances with the international definition. This move will reduce the confusion that has been known to occur when shipping these packages by air or when sent outside of the United States. This is a real concern, given the international scale of clinical trials and infectious disease investigations that are currently being conducted on a national and international scale.

Under 171.15 and 171.16, there are standing requirements for hazardous materials shippers to make oral and written reports to the National Response Center in the event of transportation releases or incidents. The emphasis placed in the proposal on making these notifications for events involving infectious substances is supported by ABSA. We encourage RSPA to work with the CDC in developing a form for filing written reports of these events to all concerned agencies.

171.134 - Class 6, Division 6.2 - Definitions and Exceptions
We propose to expand the definition of Division 6.2 (infectious substances) to include prion diseases. Prions are proteinaceous infectious particles that lack nucleic acid and are not currently covered under the definition of pathogen in 171.134. This would include, for example, agents responsible for infectious diseases such as Creutzfeld-Jacob Disease (CJD) in humans or Bovine Spongiform Encephalopathy (BSE) in animals (cattle). We feel that the special risk associated with these materials warrants their inclusion in Class 6, Division 6.2.

172.102 - Special Provisions
The inclusion of special provisions A81 and A82 in the Hazardous Materials Table is appropriate. This is a first step towards harmonization with the international requirements of the International Civil Aviation Organization (ICAO). To complete these steps, the provisions should reference the ICAO changes in A81 that are effective after June 30, 2001. Those changes expand the exemption to cover all body fluids and not just blood and blood products. The changes also increase the maximum allowable quantity in primary receptacles to 1000 milliliters instead of the current 500 milliliters.

172.432 - Emergency Notifications
ABSA endorses the proposed inclusion of the new Centers for Disease Control and Prevention toll free telephone number for reporting spills and incidents of infectious substances. This move streamlines reporting of these incidents and will enhance collection of data for future considerations.

173.6 - Materials of Trade
The expansion of this exemption is good. However, most items shipped under the materials of trade exemption need to be shipped in original hazardous materials packaging or its equivalent. Diagnostic specimens are packaged for the first time when they are collected from the physician's office. Some minimal acceptable packaging should be identified for transportation of specimens under this exemption. This should include at minimum a leak resistant bag, absorbent, and either a sealed fiberboard box or a cooler with a secured latch.

173.28 - Reuse of Packaging
ABSA recommends use of the word, "disinfect" rather than the word "decontaminate" with respect to managing packages in which there has been a leak of infectious substances. The Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogens standard does use the word, "decontaminate" in the same context. However, OSHA does require the materials used for this activity to be tuberculocidal grade disinfectants. If RSPA wishes to provide clear guidance on how to properly conduct this activity, then use of the word, "disinfection" will suffice. We also endorse the conditional exclusion of disinfection of secondary packaging when it is not contaminated by infectious substances. This same change in terminology should also be applied to Section 177.843 in which a vehicle needs to be disinfected.

173.134 - Risk Groups
ABSA endorses the concept of the use of risk group criteria as a means of classifying Division 6.2 infectious substances. Although the use of risk groups is currently part of the ICAO Technical Instructions, we are aware that the WHO does not recommend the use of their risk group criteria for this purpose. RSPA is also comfortable with the use of the risk group concept, since the use of the WHO risk groups that are within the ICAO Technical Instructions is referenced in its proposal. RSPA also allows shippers to prepare shipments as per the ICAO Technical Instructions. The current use of the WHO risk group criteria is therefore, to be supported, with the understanding that its use will be under revision by the WHO.

RSPA states that it is planning to work with WHO and CDC to assure that updated guidance for determining the risk groups for specific materials are easily available. ABSA considers this interagency communication essential to the success of the implementation of this NPR. Unfortunately, the CDC has not published or released their support for a U.S. based risk group classification. In 1993, WHO urged countries to develop their own classification. However, CDC has yet to respond. For that reason, ABSA would like to encourage RSPA to secure CDC support in developing a risk group classification prior to implementation of the NPR. Otherwise, the only U.S. based risk group classification currently available, is based on the highly technical and research environment specific "NIH Guidelines for Research involving Recombinant DNA Molecules". These guidelines are also limited in their support for an animal pathogen risk group classification. The current NIH guidelines cover only those animal pathogens that may pose theoretical risks "if inoculated" into humans. ABSA considers USDA to be an appropriate agency to assist in or develop an animal pathogen based risk group classification.

RSPA needs to be aware of the fact that although the ABSA web site currently contains a listing of risk groups, this information is largely based on international resources. With the exception of the NIH guidelines, it lacks a comprehensive U.S. based risk group classification. To reference risk groups from other countries as the basis for shipping and transportation requirements inside the U.S. would not be appropriate. In case CDC will not support and develop a U.S. based risk group classification in a timely fashion, ABSA encourages RSPA to officially cite and endorse the NIH guidelines (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html) as a source for such information. Animal pathogens warrant special consideration with respect to risk groups. Animal pathogens can adversely affect public health directly and indirectly. Some countries, such as Canada and Australia, have included animal pathogens in their shipping regulations, whereas the current list of these agents in the applicable publications of the CDC and the National Institutes of Health (NIH) is rather short and limited. The criteria used by any given country can vary. This variability points to the need for close coordination with RSPA and CDC in the development of these criteria if consistent shipping decisions regarding animal pathogens are to be made.

173.134(a)(8) Class 6, Division 6.2 -Definitions and Exceptions - Toxins
Your definition of a toxin indicates that toxins are secreted from a plant, animal, or bacterial source. For toxin investigations, these materials may be removed from the organism. The use of the word, "obtained" would be more appropriate.

173.140 - Genetically Modified Micro-organisms
ABSA agrees with RSPA's concern that "genetically modified micro-organisms may impact the environment if a shipping mishap were to occur". We recommend the recognition of "genetically modified micro-organisms" as a transportation concern and for establishing minimum acceptable packaging criteria under Class 9. Genetically modified organisms can be of significant concern for the public and the environment if an uncontrolled release occurs.

173.199 (b)(4) - Air Transportation of Infectious Substances and Diagnostic Specimens
ABSA supports the requirement for the 95 kilopascal pressure test as limited to air shipments of infectious substances or diagnostic specimens. This is in keeping with ICAO/ International Air Transport Association (IATA) requirements.

173.199 (d) - Used Health Care Products
ABSA supports RSPA's provision for exemption of health care products under certain conditions. However, ABSA questions the rationale for requiring special considerations for all "used health care products." ABSA agrees that there are certain materials that pose a potential hazard during transport, such as those involving contaminated sharps or those still containing liquid blood. However, the proposed definition of used health care products as used by RSPA refers to almost everything in a hospital and laboratory environment from a bedpan to a pacemaker, an automatic pipettor to a spectrophotometer, a blood glucose monitor to a dialysis machine, etc. Is it really RSPA's intent to regulate such items? ABSA encourages RSPA to provide clarification on this issue. ABSA would like to suggest limiting the definition to those products that have been used and are contaminated with potentially infectious body fluids or materials as outlined by the OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030). In addition, RSPA should limit the definition to those products where those hazards cannot be removed or mitigated prior to transport through disinfection.

By limiting the products covered under the NPR, RSPA clearly focuses on products that can contain potentially infectious materials and therefore might pose a risk. In addition, packing requirements for these products should be based on the actual risk. ABSA supports the packaging requirements as outlined in the NPR for products that have the potential of cutting or penetrating skin or packaging material. However, the use of watertight plastic or metal containers for both primary and secondary containers appears far too restrictive and is not supported by any actual risk data. Packaging used for returned health care products that only contain residues of dried body fluids (no liquids) should meet certain performance criteria without being limited by the NPR. Such criteria should include the provision of prohibiting the release of the material during routine transport. This would allow the manufacturer to design return packaging without the prohibitive restrictions currently proposed by the NPR.

Section 177.834 - Securing of Shipments During Transport
ABSA commends RSPA for including a requirement for Division 6.2 materials to be secured in transport, thus averting potential exposures to such materials and the clean-up and potential treatment of personnel.

We thank you for the opportunity to review this document, and your consideration of these comments.

Sincerely,

Debra Hunt, Dr.PH, RBP, CBSP (ABSA)
President, American Biological Safety Association