April 18, 2001 - Department of Transportation Proposed Rulemaking on Infectious Substances and Genetically Modified Microorganisms

The American Society for Microbiology (ASM) appreciates the opportunity to submit comments on the Department of Transportation (DOT), Research and Special Programs Administration (RSPA), Notice of Proposed Rulemaking, Hazardous Materials, Revisions to Standards for Infectious and Genetically Modified Microorganisms [Federal Register, January 22, 2001, 66: 6942-6962]. The ASM is the largest single life science society in the world, with over 42,000 members, representing a broad spectrum of subdisciplines in the microbiological sciences, including medical, clinical, environmental, and public health microbiology as well as infectious diseases. The ASM has a history of bringing its scientific, educational, and technical expertise to bear on issues surrounding the safe and appropriate study, handling, and exchange of pathogenic microorganisms. ASM members work in research, clinical, industrial, and government laboratories where microorganisms and infectious substances are transported on a regular basis. The ASM firmly supports safe and proper procedures for the shipment of biological materials.

The following comments highlight a number of significant problems regarding the RSPA proposals.

General Problems and Compliance Issues

The ASM appreciates the DOT RSPA efforts to harmonize U.S. regulations with U.N. recommendations and with the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air as well as the agency's efforts to create consistency with other applicable federal shipping regulations to prevent confusing and conflicting requirements. However, we strongly question whether the proposed RSPA revisions will actually enhance compliance and safety. The DOT states that this revision is needed because CDC has received 400 reports per year on problems related to transport of infectious substances. It should be noted that the examples cited may be examples of poor compliance with existing standards and recommended practices. If the proposed new revisions are being put forth because of noncompliance with current RSPA standards, then the problem appears to rest with those who are failing to comply with those standards, and the proposed new standards risk unduly burdening others who are in compliance. It is valid to establish standards that conform with existing international standards if this facilitates exchange of infectious substances and increases safety. However, caution must be exercised not to overly regulate domestic transport in the effort to conform to international standards.

Etiologic agents encompass a broad category of organisms, cells, and viruses which pose differing levels of risk. All etiologic agents by definition are potentially infectious to plants, animals or humans; however, not all cause communicable disease and the risk for others is extremely small outside special conditions. Special conditions required for infection, not usually encountered during transport of cultures, include such factors as dosage, aerosolization, stage of development, and in some cases transmission by a vector, e.g. mosquito or other biting insect. It must be emphasized that among the organisms considered to be etiologic agents are species which are part of the human flora or environment. That is, these are organisms that we are exposed to on a daily basis with no untoward effect. The biology of organisms which are etiologic agents and viruses is considered by the Public Health Service (PHS) in developing a classification system currently used which includes appropriate packaging requirements to eliminate or minimize risk in transport of these agents.

Complexity and Reporting Issues

Taken as a whole, the RSPA proposals are extraordinarily complex, making them very difficult to understand for their intended audiences. Indeed, ASM members find that, as part of their routine interactions with federal agencies, the current rules are subject to different interpretation by officials and experts within the same and among different federal agencies. Similar difficulties can be expected on the basis of the ASM review of the proposed revisions

This complexity is further compounded because certain information that will be essential for implementing the proposed rules, such as the listing posted on the American Biological Safety Association website, does not appear to be up to date. Moreover, the proposals indicate that risk group assignment lists from private and public-sector agencies in many different countries may be used for updating such information, without explaining how discrepancies will be reconciled. Hence, this component of the proposed RSPA revisions is likely to remain an impediment to individuals and institutions that will be trying to comply with the revisions.

ASM agrees with the proposed RSPA revisions that emergency notification paperwork should include pertinent information, such as CDC telephone numbers to expedite efforts to report accidents and similar events involving possible leakage of infectious substances during shipments. However, to keep paperwork to a minimum, ASM believes the reporting requirement should be simplified so that the same information is reported to a single agency, albeit with both CDC and DOT RSPA having access to that information as needed.

Inappropriate Treatment of GMOs

The ASM is particularly concerned about an important fundamental problem with the RSPA proposal, namely that its treatment of genetically modified organisms (GMOs) is not rooted in sound science and is inconsistent with the NIH Guidelines for Research involving Recombinant DNA molecules. The safety record of research with recombinant molecules is well established and GMOs are shipped in compliance with the standards for shipment of microorganisms on the basis of their hazard to the environment, plants, animals and humans (Appendix H. Shipment, NIH Guidelines for RDNA). Host organisms or viruses are required to be shipped as etiologic agents, regardless of whether they contain recombinant DNA, if they are regulated as human pathogens by the Public Health Service (42 Code of Federal Regulations, Part 72) or as animal pathogens or plant pests under the U.S. Department of Agriculture, Animal and Plant Health Inspection Service (Titles 9 and 7 Code of Federal Regulations). The ASM agrees that GMOs that may be hazardous should be labeled and handled accordingly. However, most GMOs pose no special risks to human health or the environment. Hence, the proposed Class 9 blanket categorization for GMOs must be carefully reconsidered because in its current form, it is scientifically meaningless and needlessly burdensome and likely to impede essential research and development in the United States.

Shipments of biological materials, including many GMOs, between collaborating scientists are an essential, everyday occurrence in modern research, and are critical to scientific progress and improvements in public health. The sequencing of the genomes of many organisms necessitates the use of recombinant microorganisms, and future research to understand the functions and contributions of human genes will depend on international collaborative research using recombinant microorganisms. Any change in or additional regulations for the shipment of biological cultures and materials could have an unnecessary deleterious effect on thousands of academic, medical, governmental, corporate and scientific organizations.

The ASM believes that the principle of sound science and the NIH Guidelines for RDNA should undergird U.S. efforts to harmonize these and other international regulations. Although these revisions represent a laudable effort to find international consistency for shipments of GMOs, implementing the current version of the RSPA proposals could seriously hamper GMO research in academic and company settings. Meanwhile, the proposals grant exemptions to federal agencies or employees in dealing with shipments of GMOs, thereby establishing a system that appears to be unjustified and discriminatory. At a minimum, the proposed definitions of Class 9 should be in conformity with the risk classifications in the NIH RDNA Guidelines that are used by NIH, NSF, USDA and DOD and are subject to periodic review and revision.

Inappropriate Terminology

The ASM objects to several cases of misuse of terminology, including that used for describing viruses, microorganisms, and toxins throughout the DOT RSPA Notice of Proposed Rulemaking. For example, in most cases, "pathogen" should substitute for "microorganism," and the term "infectious material" often is used inaccurately because the potentially infectious material being referred to may no longer be alive, may be avirulent, or otherwise may be incapable of causing disease.

Undue Impact on Diagnostic/Clinical Laboratories

The transport of diagnostic specimens and cultures is vital to the national health, and their transport must be efficient and cost effective. It is stated that the regulations will "distinguish between a diagnostic specimen known or suspected to contain an infectious substance and one sent for routine testing." This distinction is unclear because specimens submitted for testing in a microbiology laboratory are furnished for the very purpose of identifying infectious substances that they may contain. Microbiology specimens are rarely submitted for routine testing in the manner that specimens typically are submitted to chemistry or hematology laboratories for clinical testing. Furthermore, diagnostic specimens submitted to one laboratory (e.g., microbiology) should not be handled differently from the same specimen submitted to another lab (e.g., chemistry).

The regulation proposes "a complete exception from the HMR for diagnostic specimens transported by private or contract motor carriers." This implies that diagnostic specimens transported by air will be regulated. Many specimens are submitted to reference laboratories for testing. These labs may be located locally or may require air shipment of specimens to a distant laboratory. This is particularly true for highly specialized tests. The ASM believes that fully implementing many of the RSPA proposals pertaining to infectious substances could seriously impact routine and specialized testing. Currently, specialized tests are performed for all diagnostic laboratories in a limited number of facilities, and large regional commercial laboratories perform routine tests for small diagnostic laboratories. Transport of specimens to these facilities as dictated by the RSPA proposal would be prohibitively expensive for all diagnostic and clinical laboratories, including physician office laboratories, small clinical testing laboratories, and large medical center laboratories. The costs of special packaging could far exceed the costs that the federal Health Care Financing Administration sets as reimbursable for conducting such tests, thus discouraging the use of these diagnostic tests to the detriment of patient care.

It is unclear how proficiency test samples will be handled. Many clinical laboratories are required by law to be tested for proficiency by successfully identifying coded samples of known cultures, including etiologic agents, received from an outside testing organization. Regulations established as a result of the Clinical Laboratory Improvement Act of 1967 require proficiency testing of all microbiology services. If the contents of the proficiency test samples are identified with the packaged material, then the proficiency evaluation is compromised.

The ASM questions the requirement within the proposed RSPA revisions that pertains to "used health care products." Although many such products might be contaminated with small amounts of dried blood, contact with such products rarely, if ever, leads to infection in individuals who handle such items routinely (e.g. laboratory workers and medical waste handlers). Moreover, any laboratory or clinical facility working with infectious agents belonging to Risk Group 3 or 4 is required under National Institutes of Health and Centers for Disease Control and Prevention guidelines to decontaminate any equipment or materials exposed to those agents. Thus, used health care products actually represent a low risk to shippers and other handlers who inadvertently come in contact with them. Furthermore, the proposed RSPA revisions are an unnecessary regulation of products for which manufacturers of such items typically provide extensive information about disinfection procedures and existing federal agencies regulate the disinfection of equipment exposed to agents of high risk.

The ASM appreciates the opportunity to provide comments on the proposed DOT rulemaking and would be pleased to discuss the above concerns with the Department of Transportation.