{"operation":"document","citation":"67 FR 53118","title":"Hazardous Materials: Revision to Standards for Infectious Substances","source_type":"rulemaking","agency":"Research and Special Programs Administration","status":"historical","official":true,"published_on":"2002-08-14","effective_on":"2002-10-01","summary":"RSPA is revising transportation requirements for infectious substances, including regulated medical waste, to: adopt defining criteria and packaging requirements consistent with international standards; revise the current broad exceptions for diagnostic specimens and biological products; and authorize bulk packaging options for regulated medical waste consistent with requirements in international standards and DOT exemptions. These revisions will assure an acceptable level of safety for the transportation of infectious substances, and facilitate domestic and international transportation.","machine_formats":{"json":"https://regulus.evalyn.ai/document/federal-register-02-20118.json","markdown":"https://regulus.evalyn.ai/document/federal-register-02-20118.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-02-20118","source_url":"https://www.federalregister.gov/documents/2002/08/14/02-20118/hazardous-materials-revision-to-standards-for-infectious-substances","body":"Federal Register, Volume 67 Issue 157 (Wednesday, August 14, 2002) [Federal Register Volume 67, Number 157 (Wednesday, August 14, 2002)] [Rules and Regulations] [Pages 53118-53144] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 02-20118] [[Page 53117]] ----------------------------------------------------------------------- Part III Department of Transportation ----------------------------------------------------------------------- Research and Special Programs Administration ----------------------------------------------------------------------- 49 CFR Part 171 et. al. Hazardous Materials: Revision to Standards for Infectious Substances; Final Rule Federal Register / Vol. 67, No. 157 / Wednesday, August 14, 2002 / Rules and Regulations [[Page 53118]] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Research and Special Programs Administration 49 CFR Parts 171, 172, 173, 177, and 178 [Docket No. RSPA-98-3971 (HM-226)] RIN 2137-AD13 Hazardous Materials: Revision to Standards for Infectious Substances AGENCY: Research and Special Programs Administration (RSPA), DOT. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: RSPA is revising transportation requirements for infectious substances, including regulated medical waste, to: adopt defining criteria and packaging requirements consistent with international standards; revise the current broad exceptions for diagnostic specimens and biological products; and authorize bulk packaging options for regulated medical waste consistent with requirements in international standards and DOT exemptions. These revisions will assure an acceptable level of safety for the transportation of infectious substances, and facilitate domestic and international transportation. DATES: Effective Date: This final rule is effective October 1, 2002. Voluntary Compliance Date: Voluntary compliance is authorized 30 days following publication of this final rule. Incorporation by Reference Date: The incorporation by reference of publications listed in this final rule has been approved by the Director of the Federal Register as of October 1, 2002. FOR FURTHER INFORMATION CONTACT: Susan Gorsky (202) 366-8553, Office of Hazardous Materials Standards, Research and Special Programs Administration. SUPPLEMENTARY INFORMATION: List of Topics I. Background II. Comment Summary A. Pending Revisions to the UN Recommendations B. Infectious Substance Definition C. Packaging Requirements for Infectious Substances D. Exceptions for Domestic Shipments of Infectious Substances E. Diagnostic Specimens F. Biological Products G. Genetically Modified Micro-Organisms H. Regulated Medical Waste I. Used Health-Care Products J. Hazard Communication K. Training L. Contaminated Food and Food Products III. Section-by-Section Review IV. Coordination with Other Federal Agencies V. Security Issues VI. Regulatory Analyses and Notices A. Executive Order 12866 and DOT Regulatory Policies and Procedures B. Executive Order 13132 C. Executive Order 13175 D. Regulatory Flexibility Act E. Paperwork Reduction Act F. Regulation Identifier Number (RIN) G. Unfunded Mandates Reform Act H. Environmental Assessment I. Background On January 22, 2001, the Research and Special Programs Administration (RSPA, we) published a notice of proposed rulemaking (NPRM; 66 FR 6941) to revise the current requirements in the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of infectious substances, including regulated medical waste. The NPRM also proposed new requirements applicable to the transportation of genetically modified micro-organisms. The NPRM proposed the following changes to the HMR: Adoption of new classification criteria for infectious substances based on defining criteria developed by the World Health Organization (WHO) and consistent with standards contained in the United Nations Recommendations on the Transport of Dangerous Goods (UN Recommendations) and the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions). Revision of current packaging requirements for Division 6.2 materials for consistency with international performance standards. Elimination of the current exception from requirements in the HMR for diagnostic specimens. We proposed certain packaging and hazard communication requirements. Diagnostic specimens transported in dedicated motor vehicles by private or contract carriers would continue to be excepted from most requirements in the HMR. Modification of the current exception from requirements in the HMR for biological products, limiting the exception to biological products licensed for use under current Food and Drug Administration (FDA) or U.S. Department of Agriculture (USDA) regulations. New transportation requirements for the transportation of genetically modified micro-organisms consistent with the UN Recommendations. New bulk packaging options for the transportation of regulated medical waste (RMW), based on current exemption provisions. New hazard communication requirements for shipments of Division 6.2 materials. II. Comment Summary We received 46 comments on the NPRM from industry associations, laboratories, medical waste transporters, state departments of transportation and public health, a blood bank, and private citizens. Most were supportive of our effort to harmonize the HMR requirements applicable to the transportation of infectious substances with international requirements, and of proposals to enhance the safe transportation of diagnostic specimens and biological products. Based on comments received and our discussions with other Federal agencies responsible for regulating infectious substances and genetically modified micro-organisms, this final rule incorporates the following changes to the HMR: New classification criteria for infectious substances based on defining criteria developed by WHO and consistent with standards contained in the UN Recommendations and the ICAO Technical Instructions. Revised packaging requirements for Division 6.2 materials consistent with international performance standards. Revised materials of trade exceptions to include certain diagnostic specimens, biological products, and RMW. This final rule includes more specific packaging requirements for such materials of trade than were proposed in the NPRM. New packaging and hazard communication requirements for shipments of diagnostic specimens consistent with international requirements. Diagnostic specimens transported in dedicated motor vehicles by private or contract carriers are excepted from most requirements of the HMR. This final rule also clarifies that diagnostic specimens that contain a Risk Group 1 pathogen, do not contain a pathogen, or in which the pathogen is neutralized or inactive, are not subject to HMR requirements. Modification of the current exception from requirements in the HMR for biological products. This final rule revises the proposal in the NPRM to specify that the exception is limited to biological products, including experimental products, subject to Federal approval, permit, or licensing requirements, such as those required by FDA or USDA. [[Page 53119]] New bulk packaging options for the transportation of RMW, based on current exemption provisions. The packaging options proposed in the NPRM are modified in this final rule to reflect commenters' concerns about specifications for the packagings. New hazard communication requirements for bulk shipments of RMW to assist emergency responders to identify such shipments. In discussions during development of this final rule, several federal agencies involved in the regulation of genetically modified organisms (i.e., the Environmental Protection Agency (EPA) and the Department of Agriculture (USDA)) commented that the process of genetically modifying an organism does not a priori make that organism a hazard. Rather, the product of the modification must be evaluated for potential risk. As several federal agencies currently regulate genetically modified organisms, the proposals in the NPRM concerning genetically modified organisms are not adopted in this final rule. Comments we received in response to the NPRM are discussed in detail below. A. Pending Revisions to the UN Recommendations Most commenters support our proposal to harmonize the HMR requirements for infectious substances with the international standards. Two commenters note the United Nations may be developing a complete revision to its current recommendations for the transportation of infectious substances. According to these commenters, the UN may change the WHO risk group system as applied to transportation and may ``radically'' simplify current transportation requirements. These commenters advise us to postpone revising the HMR until the United Nations completes its work. The commenters are correct. The UN Committee of Experts on the Transport of Dangerous Goods is considering revisions to the requirements in the UN Recommendations applicable to the transport of infectious substances and genetically modified micro-organisms. However, it is not certain whether any amendment will be adopted during the 2001-2002 biennium. Indeed, as yet the UN Committee of Experts has not received a formal proposal. Given this uncertainty, we do not agree with delaying action to harmonize the HMR requirements for infectious substances with current international standards. If the UN Committee of Experts adopts revisions to the UN Recommendations for transporting infectious substances, we will consider such revisions in a future rulemaking. One commenter notes the proposal as it relates to diagnostic specimens is not consistent with current requirements for transporting diagnostic specimens in the ICAO Technical Instructions. This is true; as we noted in the January 2001 NPRM, the proposal for shipping diagnostic specimens is consistent with a proposal for the UN Recommendations, since adopted. Since publication of the NPRM, the ICAO Dangerous Goods Panel has also adopted these amendments. As a result, the 2003-2004 edition of the ICAO Technical Instructions will be consistent with the UN Recommendations and this final rule. B. Infectious Substance Definition In the NPRM, consistent with current requirements in the UN Recommendations, we proposed to define infectious substances, or Division 6.2 materials, to mean materials known to contain or suspected to contain a pathogen with the potential to cause disease upon exposure. We further proposed to require Division 6.2 materials to be assigned to risk groups using defining criteria developed by WHO. WHO defines four risk groups for infectious substances based on pathogenicity, mode and ease of transmission, degree of risk to individuals and communities, and reversibility of the disease through known and effective preventative agents and treatment. Risk Group 1 includes micro-organisms unlikely to cause human or animal disease. In the NPRM, we proposed that Risk Group 1 materials not be subject to regulation under the HMR. Several commenters oppose using the WHO risk group criteria for infectious substances regulated under the HMR. They note that the WHO system was intended for assessing and addressing risks to researchers and health care workers in laboratory environments, not for transportation. We do not agree. While it is true the WHO risk groups were not originally intended for transportation environments, they do provide a relatively simple way to delineate and differentiate risks associated with specific pathogens. As such, the WHO risk groups are a useful tool for assessing the degree to which specific pathogens should be regulated in transportation, based on the potential risk to transportation workers and the general public. Other risk systems (for example, the biosafety level guidelines in the Centers for Disease Control and Prevention/National Institutes of Health (CDC/NIH) publication Biosafety in Microbiological and Biomedical Laboratories) were also developed for use in laboratories rather than in transportation. These systems can be more difficult to apply for transportation purposes than the WHO risk groups. Some commenters opposed to the use of the WHO risk groups recommend we create an advisory group to assign risk group classifications for infectious substances in transportation. We do not believe this is a practical or feasible approach because of the length of time that would be involved in establishing the advisory group and awaiting the results of its deliberations. Other commenters opposed to use of the WHO risk groups suggest we adopt government or industry consensus standards for risk group assignments, such as those developed by NIH. The NIH and WHO lists are very similar; NIH has published specific names of micro- organisms assigned to each risk group in a table. Although not complete, the NIH list is a useful reference source for identifying the appropriate risk group for a given pathogen. (The NIH guidelines can be found at http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html ). There are other risk group listings that also provide useful guidance for assigning a specific pathogen to a risk group, including a list developed by the American Biological Safety Association (available on line at http://www.absa.org/riskgroups/index.htm ) and the list of agents in the CDC/NIH publication Biosafety in Microbiological and Biomedical Laboratories (available on line at http://www.cdc.gov/od/ohs/biosfty/biosfty.htm ). We do not agree the HMR should incorporate one or more of these lists by reference into the HMR. However, in this final rule we are including these lists in the table of informational materials in Sec. 171.7(b). Instead of the WHO risk groups, one commenter suggests we utilize the existing Packing Group system in the HMR to address differing risks associated with the transportation of specific infectious substances. Thus, the commenter suggests Packing Group I would contain virulent pathogens that have a high risk of airborne infection, readily penetrate unbroken skin, are extremely persistent in the environment, and for which effective preventative or treatment measures are not readily available. Packing Group II would contain pathogens with a significantly lower risk of airborne infection, the primary exposure risk of which is entry through broken skin or contact with mucous membranes, and for which effective preventative or [[Page 53120]] treatment measures are readily available. Packing Group III would contain pathogens classed as WHO Risk Group 2 materials. We do not agree the existing Packing Group system provides a viable alternative to the WHO risk groups. As set forth in the NPRM, the WHO risk groups are used to identify pathogens not subject to regulation (Risk Group 1) or to identify certain pathogens (Risk Group 2 and 3) that may be shipped under certain exceptions, such as materials of trade. Unless an exception is authorized, all Risk Group 2, 3, and 4 infectious substances must be transported in specification triple packagings authorized under the HMR. In addition, they must be marked and labeled in accordance with applicable requirements, and accompanied by appropriate shipping and emergency response documentation. The packing group system suggested by the commenter would require shippers to distinguish between Risk Group 2 and 3 infectious substances when making packaging decisions, and would be more difficult, confusing, and burdensome to implement than the system proposed in the NPRM. The NPRM proposed to assign infectious substances to risk groups based on the known medical history of the patient or animal, endemic local conditions, symptoms of the patient or animal, or professional judgement concerning the individual circumstances of the patient or animal. One commenter suggests this provision could endanger patient confidentiality and violate medical privacy regulations. We disagree. The proposal does not require health care professionals to disclose medical histories or patient symptoms. Rather, the proposal suggests these factors should be considered as the health care professional assigns an infectious substance to a risk group for purposes of transportation. Disclosure of the factors contributing to this determination or the name of the patient is not required. Further, the requirement for inclusion of an itemized list of contents within a package containing Division 6.2 materials requires a shipper only to identify the material. There is no requirement to include a patient name on the itemized list. One commenter suggests we modify the list of factors used to determine risk group assignments to include the type of test ordered on the specimen. We do not believe it is necessary to specify this information as a factor in making risk group determinations. Shippers should make risk group assignments based, in part, on professional judgement concerning the individual circumstances of the patient or animal. Such professional judgement should include the types of tests ordered or other factors. One commenter recommends we regulate infectious substances meeting the defining criteria for a Risk Group 1 material for transportation purposes We disagree. By definition, Risk Group 1 infectious substances are micro-organisms unlikely to cause human or animal disease. Risk Group 1 infectious substances in transportation pose little or no risk to transportation workers or to the general public. Risk Group 1 infectious substances are not subject to regulation under international transportation requirements because the risk posed by such materials is very low. There is no compelling safety rationale for regulating such materials under the HMR. A number of commenters suggest specific revisions to the proposed definition of infectious substances. For example, several recommend including prions in the definition. Prions are not micro-organisms, but are proteinaceous infectious particles consisting of an abnormal isoform of a normal cellular protein. Prions are implicated as a cause for neuro-degenerative diseases such as kuru and Creutzfeldt-Jacob disease in humans, and bovine spongiform encephalopathy and scrapie in animals. We agree with commenters that a strict reading of the proposed definition in the NPRM would appear to exclude prions; therefore, we have modified the definition to specifically include them. We further revised the definition for clarity and to remove superfluous or inaccurate terminology. One commenter suggests limiting regulation of infectious substances in transportation to those capable of infecting ``immunocompetent humans and animals.'' For purposes of the HMR, ``immunocompetent'' would mean the human or animal possesses an effective body immune mechanism with no reduced immunity to infection by any known cause. We disagree. The WHO risk group system assigns infectious substances to risk groups based on their ability to infect immunocompetent humans and animals. Thus, it is not necessary to make this explicit in the HMR. Accordingly, in this final rule we are defining Division 6.2 materials using the WHO risk group criteria. Division 6.2 materials must be assigned to risk groups based on the degree to which they cause injury through disease, with Risk Group 1 presenting the lowest risk and Risk Group 4 presenting the highest risk. Assignments to risk groups are based on the known medical history of the patient or animal, endemic local conditions, symptoms of the patient or animal, or professional judgement concerning the individual circumstances of the patient or animal. Division 6.2 materials assigned to Risk Group 1 are excepted from all HMR requirements, unless they meet the definition of another hazard class. C. Packaging Requirements for Infectious Substances In the NPRM, we proposed to incorporate several changes to the infectious substances regulations applicable to packaging requirements and performance tests. The changes were intended to make the HMR requirements consistent with the UN Recommendations and ICAO Technical Instructions For example, we proposed to require manufacturers to meet UN marking requirements for packagings represented as conforming to the specifications for infectious substances packagings in the HMR. In addition, we proposed to require manufacturers to retain packaging design qualification records and to retest packagings every 24 months. Further, we proposed to replace the current requirement for a water immersion test with a water-spray test to simulate exposure to rainfall, as required by the ICAO Technical Instructions. Similarly, we proposed to incorporate the selective testing provisions in the UN Recommendations and ICAO Technical Instructions. These provisions allow variations in the primary receptacles within the secondary packaging, without further testing of the completed package, if an equivalent level of performance is maintained. Commenters endorse these proposals. We are adopting them in this final rule without change. One commenter suggests a more stringent packaging requirement for infectious substances. The commenter recommends we replace the current triple packaging requirement (water-tight primary receptacle, water- tight secondary packaging, and outer packaging) with a quintuple packaging. In the quintuple packaging, the primary receptacle is enclosed in a sealed plastic bag with absorbent material inside a watertight primary container inside a watertight secondary container inside a tertiary container or overpack. We disagree. The accident record demonstrates a triple packaging meeting the performance standard established in the HMR is sufficient to contain the material under normal conditions of transportation. [[Page 53121]] D. Exceptions for Domestic Shipments of Infectious Substances In the NPRM, we proposed to expand the materials of trade (MOTS) exceptions currently permitted under Sec. 173.6 of the HMR. The proposal expanded the MOTS exception to include certain biological products, diagnostic specimens, and RMW, including cultures and stocks. MOTS include hazardous materials carried by private motor carriers engaged in a principal business other than transportation, such as lawn care, plumbing, welding, and door-to-door sale of consumer goods. The MOTS exception limits the maximum gross weight of MOTS that may be carried on a motor vehicle and includes minimum packaging and hazard communication requirements. As proposed in the NPRM, the MOTS exception for infectious substances specified combination packagings, with limitations on capacity. A number of commenters address the proposed MOTS exception for infectious substances. Several commenters oppose the exception, suggesting it is too broad and does not provide adequate packaging or hazard communication. Other commenters support the exception, but recommend we incorporate minimal acceptable standards for packaging. These commenters note that most items shipped under the MOTS exception must be shipped in their original packaging or the equivalent. However, biological products, diagnostic specimens, and RMW are packaged for the first time when they are collected at the site from which they will be shipped. Thus, these commenters suggest the inner packaging should be puncture- and leak-resistant and there should be sufficient absorbent material for the contents of the inner packaging. We agree with commenters that the MOTS exception for Division 6.2 materials should include general packaging standards. Therefore, in this final rule, we are adding performance requirements for combination packagings authorized under the MOTS exception for transportation of Division 6.2 materials. The inner packaging of the combination packaging must be leak tight for liquids, and the outer packaging must contain absorbent material sufficient to absorb the entire contents of the inner packagings. For sharps, which are objects that can pierce certain types of packaging, the inner packaging of the combination packaging must be constructed of a rigid, puncture-resistant material. For all Division 6.2 materials, the outer packaging must be a strong, tight packaging that is securely sealed. Note that Division 6.2 materials shipped in conformance with the MOTS exception are subject to all applicable requirements in Sec. 173.6. This includes requirements to mark packages with a common name or proper shipping name, and to inform the motor vehicle operator of the presence of a hazardous material and the requirements of Sec. 173.6. A commenter asks us to clarify the MOTS exception for RMW, with respect to home health care providers. Specifically, this commenter believes the NPRM was confusing in its treatment of waste generated from households. The commenter states the NPRM proposed the MOTS exception in Sec. 173.6 as appropriate for home health care providers. At the same time, the NPRM provided a complete exception in Sec. 173.134 from HMR requirements for medical waste generated from households and transported in accordance with applicable state or local requirements. The exception for medical waste generated from households applies to waste collected by local sanitation workers along with trash, garbage, and other non-medical household waste. The MOTS exception applies to RMW generated through home treatment of medical conditions by professional health care providers. These health care providers remove such waste and transport it elsewhere for disposal. One commenter recommends the HMR include an exception from all transportation regulatory requirements, except for minimal packaging standards, for Risk Group 2 materials transported by highway. The commenter did not provide a reason for this recommendation. We disagree. Risk Group 2 infectious substances can pose risks to transportation workers and the general public. We believe they should be regulated in the same manner as Risk Group 3 infectious substances. One commenter suggests the final rule should include an exception for environmental microbiological samples collected in the field to evaluate occupational and residential exposure risks. An example is a piece of moldy wallboard. The organisms in such samples are predominantly from the environment rather than humans, and therefore pose a limited risk of infection to the individual or the community. We agree and so modified the list of materials excepted from the HMR to include environmental microbiological samples being transported for analysis and/or testing. Note, however, that a material or object known or suspected to be contaminated with an infectious substance must be transported in accordance with all applicable HMR requirements. The same commenter also expresses a concern about the effect of the proposals in the NPRM on samples shipped to laboratories to evaluate their proficiency in analyzing and identifying pathogens and other materials. The commenter is concerned the NPRM would require such samples to be identified in shipping documentation or on labels. In fact, this is not the case. The HMR requires the technical name of an infectious substances to be shown in parentheses as part of the basic shipping description on shipping papers and package markings. However, the definition of ``technical name'' in Sec. 171.8 of the HMR permits use of a generic description in place of the technical name for proficiency testing. Thus, an infectious substance sample sent to a laboratory for proficiency testing may show a generic microbiological description, such as bacteria, myobacteria, fungus, or viral sample, as part of the shipping description. Packaging, marking, and labeling the proficiency testing sample as an infectious substance and using a generic technical name should not compromise proficiency testing programs. E. Diagnostic Specimens In the NPRM, we proposed regulations applicable to the transportation of diagnostic specimens consistent with the UN Recommendations. Diagnostic specimens are human or animal material being transported for diagnostic or investigational purposes. We proposed a new entry in the Hazardous Materials Table--``Diagnostic Specimen.'' We did not propose a UN number, warning label, or packing group assignment. As proposed in the NPRM, diagnostic specimens meeting the definition of a Risk Group 4 material would be classed and required to be transported as Division 6.2 materials, UN 2814 or UN 2900. All other diagnostic specimens would be packaged in non-specification packagings meeting minimum performance criteria. Under the proposal, packages containing diagnostic specimens would be required to be marked ``Diagnostic Specimens.'' Diagnostic specimens shipped in accordance with these provisions would be excepted from all other HMR requirements, except for incident reporting for diagnostic specimens transported by aircraft. [[Page 53122]] Several commenters oppose the NPRM proposal for diagnostic specimens. These commenters suggest that requirements for the shipment of diagnostic specimens should be applied based on whether a specimen could reasonably be suspected of being infectious. According to these commenters, any shipments other than routine screening samples or samples transported to investigate non-communicable diseases or conditions should be fully regulated as Division 6.2 materials. As we noted in the NPRM (66 FR 6944), we issued an ANPRM under this docket (63 FR 46844; September 2, 1998) proposing a regulatory regime for diagnostic specimens similar to this commenter's suggestion. Commenters to the ANPRM almost unanimously opposed this approach, stating it would be difficult and costly to implement. Commenters to the ANPRM also stated such a requirement could result in shipment delays. This would make early detection and treatment of disease difficult, and could significantly increase health care costs. We agreed. The NPRM proposal specifies a more practical, cost-effective, and easy-to-understand regulatory system for diagnostic specimens, consistent with requirements established in the UN Recommendations. A number of commenters suggest the table entry for diagnostic specimens is ambiguous and may cause confusion. The table entry indicates that diagnostic specimens are regulated as hazardous materials. However, the specific provisions proposed for transportation of diagnostic specimens except such shipments from most requirements applicable to hazardous materials. Several commenters recommend we remove the entry from the table, to clarify that diagnostic specimens are not regulated as hazardous materials. We disagree. In fact, the NPRM proposed a table entry for diagnostic specimens precisely to indicate diagnostic specimens would be regulated as hazardous materials under the HMR. There are a number of materials listed in the table as hazardous materials that are excepted from most HMR requirements, as we proposed to do for diagnostic specimens. For example, lithium batteries are regulated for transportation purposes as a hazardous material and are listed in the table, but are excepted from many requirements of the HMR when shipped in accordance with the provisions in Sec. 173.185. One commenter notes that diagnostic specimens are usually shipped with a transport media. The transport media preserves the specimen, prevents overgrowth, and facilitates isolation and analysis. This transport media may inactivate or disable any pathogens contained in the specimen. The commenter states that the NPRM overlooks this aspect of diagnostic specimens shipments, exaggerating the risk associated with transportation. Other commenters agree and suggest the final rule should clarify that if no pathogen is present in the diagnostic specimen or if the pathogen is neutralized, then the specimen is not regulated under the HMR. We agree. In this final rule, we added diagnostic specimens in which no pathogen is present or the pathogen is neutralized to the list of materials not subject to regulation as infectious substances under the HMR. Note, however, that a transport media used in the shipment of infectious substances may itself be a hazardous material--i.e., it meets the definition of one of the defined hazard classes based on flammability, corrosivity, toxicity, or other hazard characteristic. If so, the shipment must be transported in accordance with HMR requirements for the specific hazard class. Note, also, that a diagnostic specimen shipped in a packaging with a neutralizing agent designed to function only if the inside packaging containing the diagnostic specimen ruptures or breaks, must be shipped in accordance with the requirements applicable to diagnostic specimens in Sec. 173.199. Several commenters suggest the regulations should take into account the physical nature of a diagnostic specimen when prescribing packaging requirements. For example, commenters state certain diagnostic samples, such as dried blood spots, fecal smears, and skin punches, do not present the same risks in transportation as liquid or semi-solid diagnostic samples. Similarly, commenters state urine and oral tissues are incapable of transmitting disease in the same manner as blood. These commenters recommend modification of the regulations to distinguish between diagnostic specimens that pose a threat of infection to transport workers and the general public, and those that do not. We disagree. Solid-form diagnostic specimens potentially containing infectious substances do present a risk of infection, as do urine and oral tissues. Although this risk may be less than for blood, we believe the minimal packaging standards for the transportation of diagnostic specimens should apply consistently to all materials meeting the definition of a diagnostic specimen in this final rule. Moreover, the packaging standards established in this final rule do distinguish between solid- and liquid-form diagnostic specimens. For example, the capacity limits for liquid diagnostic specimens are less. Further, liquid diagnostic specimen packagings transported by aircraft must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa. Several commenters address the specific packaging requirements proposed for the transportation of diagnostic specimens. The NPRM proposed to require diagnostic specimens to be packaged in primary receptacles packed inside secondary packaging, secured in an outer packaging with suitable cushioning material. One commenter states there is no need to secure the secondary packaging inside the outer packaging, because the specimen is twice contained in leak-proof, watertight packaging with absorbent material in between. This commenter asserts the proposal adds to overall packaging costs with no transportation safety benefit. We disagree. The requirement to secure secondary packaging inside the outer packaging helps assure the integrity of the entire packaging, by preventing damage to the secondary packaging resulting from handling during transportation. Moreover, the requirement is consistent with international standards. Further, secondary packaging can be secured inside an outer packaging in several ways that do not necessarily involve tying or fastening the secondary packaging to the outer packaging. For example, if the secondary packaging fits snugly within the outer packaging, the secondary packaging would be considered to be secured within the outer packaging. In addition, several commenters state the proposed capacity limits on packages of diagnostic specimens should be more flexible to accommodate dry ice for preservation of specimens. The NPRM proposed an outer packaging capacity limit of 4L (1 gallon) for liquid diagnostic specimens, and 4 kg (8.8 pounds) for solid diagnostic specimens. These capacity limits apply to the diagnostic specimen only; packagings may be larger to accommodate dry ice used for preservation of specimens. Note, however, that shipments using dry ice are subject to applicable requirements in Sec. 173.217. Another commenter suggests the packaging requirements for diagnostic specimens should be more stringent than in the NPRM. This commenter recommends a quintuple packaging, consisting of a primary receptacle [[Page 53123]] enclosed in a sealed plastic bag contained in a primary container, inside a secondary container, inside a tertiary container. We disagree. The packaging for diagnostic specimens proposed in the NPRM is consistent with packaging requirements in the UN Recommendations. Further, the packaging suggested by the commenter would add significantly to the cost of shipping diagnostic specimens. One commenter addresses the ``diagnostic specimen'' marking requirement proposed in the NPRM. This commenter states the proposed marking requirement is redundant and provides no transportation benefit. We disagree. Under the proposal in the NPRM, packages containing diagnostic specimens must be marked ``Diagnostic Specimen.'' No other marking or labeling is required, nor are shipping papers required; thus, it is difficult to see how the proposed marking could be ``redundant.'' The marking is intended to communicate a potential hazard to transportation workers. Diagnostic specimens shipped in accordance with the provisions in the NPRM could contain infectious material, and the marking indicates transportation workers should take appropriate precautions if the package is damaged or leaking. Another commenter suggests we adopt and modify the ``Excepted Quantities Label'' authorized by International Air Transport Association (IATA) standards, to indicate a shipment contains a diagnostic specimen. We believe the marking requirement in this final rule accomplishes the same goal without the additional regulatory burden that would result from a new labeling requirement. However, this final rule does not prohibit shippers from voluntarily applying the ``Excepted Quantities Label'' to such packages in addition to the ``Diagnostic Specimen'' marking. In addition to the MOTS exception previously discussed, the NPRM also proposed a complete exception from the HMR for diagnostic specimens transported by private or contract motor carriers. One commenter opposes this exception, out of concern that inadequate packaging would expose untrained emergency response personnel to potentially infectious materials. However, most commenters generally are supportive of this proposal, agreeing the packaging and procedures used for courier shipments of diagnostic specimens are sufficient to assure the safety of such shipments in transportation. Further, couriers are familiar with the materials they transport, and are trained in the application of the Occupational Safety and Health Administration (OSHA) standards for Universal Precautions for handling materials potentially containing infectious substances. Therefore, this exception is adopted as proposed in this final rule. The NPRM proposed to except diagnostic specimens prepared in accordance with proposed Sec. 173.199 from training requirements in Subpart H of Part 172 of the HMR. In lieu of training, the NPRM proposed to require offerors and transporters of diagnostic specimens to be informed of the diagnostic specimen packaging requirements. Commenters did not specifically address this aspect of the proposed requirements for diagnostic specimens in the NPRM. One commenter asked us to clarify the meaning of ``must be informed'' as used in proposed Sec. 173.199. As used in new Sec. 173.199 of this final rule, ``must be informed'' means persons who offer or transport diagnostic specimens for transportation in accordance with Sec. 173.199 must know about and be able to apply the requirements of Sec. 173.199 to specific shipments. Ther","truncated":true,"body_characters":164409}