{"operation":"document","citation":"71 FR 32244","title":"Hazardous Materials: Infectious Substances; Harmonization With the United Nations Recommendations","source_type":"rulemaking","agency":"Pipeline and Hazardous Materials Safety Administration","status":"historical","official":true,"published_on":"2006-06-02","effective_on":"2006-10-01","summary":"PHMSA is revising the transportation requirements for infectious substances, including regulated medical waste, to adopt new classification criteria, new exceptions, and packaging and hazard communication requirements consistent with revised international standards and to clarify existing requirements to promote compliance. These revisions will ensure 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-06-4992.json","markdown":"https://regulus.evalyn.ai/document/federal-register-06-4992.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-06-4992","source_url":"https://www.federalregister.gov/documents/2006/06/02/06-4992/hazardous-materials-infectious-substances-harmonization-with-the-united-nations-recommendations","body":"Federal Register, Volume 71 Issue 106 (Friday, June 2, 2006) [Federal Register Volume 71, Number 106 (Friday, June 2, 2006)] [Rules and Regulations] [Pages 32244-32263] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 06-4992] [[Page 32243]] ----------------------------------------------------------------------- Part III Department of Transportation ----------------------------------------------------------------------- Pipeline and Hazardous Materials Safety Administration ----------------------------------------------------------------------- 49 CFR Parts 171, 172, 173, and 175 Hazardous Materials: Infectious Substances; Harmonization With the United Nations Recommendations; Final Rule Federal Register / Vol. 71, No. 106 / Friday, June 2, 2006 / Rules and Regulations [[Page 32244]] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts 171, 172, 173, and 175 [Docket No. PHMSA-2004-16895 (HM-226A)] RIN 2137-AD93 Hazardous Materials: Infectious Substances; Harmonization With the United Nations Recommendations AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: PHMSA is revising the transportation requirements for infectious substances, including regulated medical waste, to adopt new classification criteria, new exceptions, and packaging and hazard communication requirements consistent with revised international standards and to clarify existing requirements to promote compliance. These revisions will ensure an acceptable level of safety for the transportation of infectious substances and facilitate domestic and international transportation. EFFECTIVE DATE: This final rule is effective October 1, 2006. Voluntary Compliance Date: Voluntary compliance is authorized 30 days following publication of this final rule. FOR FURTHER INFORMATION CONTACT: Eileen Edmonson, Office of Hazardous Materials Standards, (202) 366-8553, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation or by e-mail to [email protected] or [email protected] . SUPPLEMENTARY INFORMATION: I. Background On May 19, 2005, the Pipeline and Hazardous Materials Safety Administration (PHMSA), published a notice of proposed rulemaking (NPRM) to revise the requirements in the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180) applicable to the transportation of infectious substances affecting humans and animals, including regulated medical waste (67 FR 53118). In the NPRM, PHMSA proposed to harmonize the HMR requirements applicable to the transportation of Division 6.2 materials with requirements in the 13th and 14th Editions of the UN Recommendations for the Transport of Dangerous Goods (UN Recommendations), the 2005-2006 Edition of the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions), and the International Maritime Organization Dangerous Goods Code. Specifically, we proposed to: Revise the classification system for Division 6.2 materials from the current four-tiered risk group system to a two- tiered system--Category A and Category B. Replace the proper shipping name ``Diagnostic specimens'' with ``Biological substance, Category B.'' Adopt packaging requirements for Category A and Category B infectious substances consistent with those in the UN Recommendations and ICAO Technical Instructions. For Category B infectious substances, require the name, address, and telephone number of a person knowledgeable about the Category B infectious substance to be provided on a written document, such as an air waybill, accompanying the shipment or on the package. Permit a sample of an unknown infectious substance shipped for analysis or diagnosis to be transported as a Category B infectious substance, unless there is a strong suspicion that the unknown infectious substance meets the criteria for Category A, in which case the unknown material must be transported as a Category A infectious substance. Require sharps packagings to be securely closed and leakproof in all orientations. Require the development and implementation of transportation security plans for select agents and toxins affecting animals, as identified in 9 CFR part 121. The comment period for the proposed rule closed on July 18, 2005. PHMSA received 13 comments, all of which support revising the requirements to harmonize them with current international standards. The following companies, organizations, and individuals submitted comments: Gary Gilliam (Gilliam; RSPA-2004-16889-2); Alcoa, Inc. (Alcoa; RSPA-2004-16889-3); Steven V. Schulte (Schulte; RSPA-2004- 16889-4); The Daniels Corporation (Daniels; RSPA-2004-16889-6); Shoolah Escott (Escott; RSPA-2004-16889-7); National Solid Waste Management Association/Medical Waste Institute (NSWAM/MWI; RSPA-2004-16889-8); American Blood Centers (ABC; RSPA-2004-16889-9); Air Transport Association of America, Inc. (ATA; RSPA-2004-16889-10); Stericycle, Inc; (Stericycle; RSPA-2004-16889-11); JBM Associates, Inc. (JBM; RSPA- 2004-16889-12); American Clinical Laboratory Association (ACLA; RSPA- 2004-16889-13); Air Line Pilots Association (ALPA; RSPA-2004-16889-14); and TEN-E Packaging Services, Inc. (TEN-E; RSPA-2004-16889-15 and -16). II. Discussion of Comments A. Classification of Division 6.2 Materials The HMR currently incorporate a risk-group-based classification system for infectious substances. The regulations require Division 6.2 materials to 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. Assignment of an infectious substance to a risk group is based on the known medical history of the source patient or animal, endemic local conditions, symptoms of the source patient or animal, or professional judgment concerning individual circumstances of the source patient or animal. Division 6.2 materials assigned to Risk Group 1 are excepted from the HMR and the UN Recommendations. The current requirements for assigning pathogens to risk groups are based on the risks posed in the laboratory environment, not in the transportation environment. Pathogens in transport do not pose the same level of risk that they do in the laboratory. Laboratory workers perform extensive manipulations of infectious substances that place the workers at higher risk of infection because of accidental exposures caused by splashes or spills. Moreover, certain laboratory processes-- such as vortexing, mixing, or centrifuging--can generate aerosols or airborne particles that can place workers who perform such operations at increased risk. These conditions do not exist in transport. The risk group classification system resulted in transportation problems, including shipper confusion in assigning risk groups, and shipment delays or refusal to transport associated with carriers' and transport workers' perceptions about the risks associated with the transportation of infectious substances. A delay in transportation or a refusal to transport a specimen may have life-threatening implications for a patient or a population. Moreover, transportation problems can delay research necessary to develop treatments or slow the spread of disease, and can interfere with the [[Page 32245]] implementation of appropriate measures to address new disease outbreaks. Because of these transportation problems, the UN Committee of Experts on the Transport of Dangerous Goods worked with scientists and public health professionals at the World Health Organization (WHO), the U.S. Centers for Disease Control and Prevention (CDC), and other agencies to develop a classification scheme for infectious substances that would be more appropriate for the transportation environment. In December 2002, the United Nations adopted a number of revisions for the 13th Revised Edition of the UN Recommendations related to the transportation of infectious substances, primarily involving how infectious substances are classed and packaged. In July 2004, the UN Committee of Experts on Dangerous Goods recommended further revisions to these standards; these revisions were adopted for the 14th Revised Edition of the UN Recommendations in December 2004. At the same time, the ICAO Dangerous Goods panel adopted many of the amendments for the 14th Revised Edition of the UN Recommendations in the 2005-2006 Edition of the ICAO Technical Instructions through an addendum to the ICAO Technical Instructions. The amendments in the 13th and 14th Editions of the UN Recommendations are the result of long and thoughtful consultations among regulators, scientists, medical professionals, and the transport community. The result is a set of standards for the transportation of infectious substances that are easier to use and impose a high level of safety appropriate to the degree of risk and conditions of transport. PHMSA's May 9, 2005 NPRM proposed to harmonize HMR requirements for the transportation of infectious substances with the international standards. Commenters generally support PHMSA's efforts to more closely align the requirements for transporting infectious substances with current international requirements by adopting a two-tiered classification system. The majority of commenters state they believe the requirements will ease the movement of these materials in transit and reduce confusion, thereby increasing safety. Therefore, in this final rule, we are adopting the classification system as proposed in the NPRM. The requirements adopted in this final rule establish a two-tiered classification system for Division 6.2 materials--Category A and Category B. Category A infectious substances pose a higher degree of risk than Category B infectious substances. Category A material is an infectious substance transported in a form capable of causing permanent disability or life-threatening or fatal disease to otherwise healthy humans or animals when exposure to it occurs. An exposure occurs when an infectious substance is released outside of its protective packaging, resulting in physical contact with humans or animals. Category A infectious substances are assigned to existing identification numbers UN 2814 (for substances causing disease in humans or in both humans and animals) or UN 2900 (for substances causing disease in animals only), and are to be packaged and described according to applicable HMR provisions for these materials. The following are examples of Category A infectious substances, as designated by scientists at WHO and the U.S. Department of Health and Human Services (HHS). Please note this list is not all inclusive and is provided only as guidance. Note also that many of the entries on the list include the modifier ``(cultures only).'' For these materials, only cultures of the listed infectious substances are considered Category A infectious substances. Other forms of these infectious substances may be transported as Category B infectious substances. ------------------------------------------------------------------------ Category A infectious substances UN No. and proper shipping name Micro-organism ------------------------------------------------------------------------ UN 2814--Infectious substances Bacillus anthracis (cultures affecting humans and animals. only). Brucella abortus (cultures only). Brucella melitensis (cultures only). Brucella suis (cultures only). Burkholderia mallei-- Pseudomonas mallei--Glanders (cultures only). Burkholderia pseudomallei-- Pseudomonas pseudomallei (cultures only). Chlamydia psittaci--avian strains (cultures only). Clostridium botulinum (cultures only). Coccidioides immitis (cultures only). Coxiella burnetti (cultures only). Crimean-Congo hemorrhagic fever virus. Dengue virus (cultures only). Eastern equine encephalitis virus (cultures only). Escherichia coli, verotoxigenic (cultures only). Ebola virus. Flexal virus. Francisella tularensis (cultures only). Guanarito virus. Hantaan virus. Hantaviruses causing hemorrhagic fever with renal syndrome. Hendra virus. Herpes B virus (cultures only). Human immunodeficiency virus (cultures only). Highly pathogenic avian influenza virus (cultures only). Japanese Encephalitis virus (cultures only). Junin virus. Kyasanur forest disease virus. Lassa virus. Machupo virus. Marburg virus. Monkeypox virus. Mycobacterium tuberculosis (cultures only). Nipah virus. [[Page 32246]] Omsk hemorrhagic fever virus. Poliovirus (cultures only). Rabies and other lyssaviruses (cultures only). Rickettsia prowazekii (cultures only). Rickettsia rickettsia (cultures only). Rift Valley fever virus (cultures only). Russian spring-summer encephalitis virus (cultures only). Sabia virus. Shigella dysenteriae type I (cultures only). Tick-borne encephalitis virus (cultures only). Variola virus. Venezuelan equine encephalitis virus (cultures only). Vesicular stomatitis virus (cultures only). West Nile virus (cultures only). Yellow fever virus (cultures only). Yersinia pestis (cultures only). UN 2900--Infectious substances African swine fever virus affecting animals only. (cultures only). Avian paramyxovirus Type 1-- Velogenic Newcastle disease virus (cultures only). Classical swine fever virus (cultures only). Foot and mouth disease virus (cultures only). Lumpy skin disease virus (cultures only). Mycoplasma mycoides--Contagious bovine pleuropneumonia (cultures only). Peste des petits ruminants virus (cultures only). Rinderpest virus (cultures only). Sheep-pox virus (cultures only). Goatpox virus (cultures only). Swine vesicular disease virus (cultures only). ------------------------------------------------------------------------ A Category B infectious substance is one that does not meet the criteria for inclusion in Category A. A Category B infectious substance does not cause permanent disability or life-threatening or fatal disease to humans or animals when exposure to it occurs. Under the provisions of the 13th Edition of the UN Recommendations, adopted in December 2002, a Category B infectious substance is described as ``Diagnostic Specimen'' or ``Clinical Specimen'' and assigned to UN 3373. Currently, the HMR define a ``diagnostic specimen'' to mean any human or animal material being transported for diagnostic or investigative purposes. In accordance with current Sec. 173.199, diagnostic specimens are excepted from most HMR requirements except for minimal packaging and hazard communication. Historically, the HMR have permitted a proper shipping name, such as ``Diagnostic specimen,'' listed in the Sec. 172.101 Table to be used to describe a non- hazardous material on a shipping paper and package marking provided the UN or NA identification number is not included. See Sec. Sec. 172.202(e) and 172.303(b)(3). However, adoption of the proper shipping name ``Diagnostic specimen'' in both the international standards and the HMR resulted in some confusion on the part of both shippers and carriers who are accustomed to using these terms to refer to human or animal samples that have a low probability of containing an infectious pathogen. In addition, using these terms to describe shipments of Category B infectious substances is not completely accurate--there are many shipments of Category B infectious substances that may not be diagnostic specimens as that term is usually defined. The UN Sub-Committee of Experts on the Transport of Dangerous Goods discussed the proper shipping name issue during its July 2004 meeting and agreed to adopt a different proper shipping name for Category B infectious substances--``Biological substance, Category B.'' The UN adopted this proper shipping name for the 14th Revised Edition of the UN Recommendations, which is effective January 1, 2007; ICAO adopted the new proper shipping name through an addendum to the 2005-2006 ICAO Technical Instructions. The addendum permits use of the new proper shipping name as an alternative to ``Diagnostic Specimen'' or ``Clinical Specimen'' until January 1, 2007, at which time the new name must be used. Consistent with the revised international standards, the May 9, 2005 NPRM proposed to adopt the proper shipping name ``Biological substance, Category B'' in the HMR. No commenters opposed this proposal, and it is adopted in this final rule. Thus, a Category B infectious substance must be described as ``Biological substance, Category B'' and assigned to UN 3373. B. Packaging Requirements for Category B Infectious Substances Currently, the HMR require Risk Group 2 and 3 infectious substances (most of which will be classed as Category B infectious substances under this final rule) to be transported in triple packagings certified to comply with the performance standards in Sec. 178.609, including a drop test from a height of 9 m (30 ft), a water spray test, and a puncture test. In the NPRM, we proposed to permit Category B infectious substances to be transported in non-specification triple packagings capable of passing a drop test only at a height of 1.2 meters (3.9 feet). Commenters support this proposal. We are adopting this requirement in this final rule. The NPRM proposed to require these packagings to be capable of passing the drop test set forth in Sec. 178.603, which prescribes tests for all non-bulk packaging designs. As suggested by one commenter (TEN-E), in this final rule, we are replacing the reference to Sec. 178.603 with Sec. 178.609. The drop test established in Sec. 178.609 applies specifically to infectious substance packagings; this testing configuration more appropriately addresses the integrity issues for infectious substance packages. [[Page 32247]] The NPRM proposed to require the outer packaging of the triple pack authorized for the transportation of Category B infectious substances to be rigid; the proposal is consistent with requirements adopted for air shipments of Category B infectious substances in the ICAO Technical Instructions. One commenter (ACLA) suggests this requirement is unnecessary because a packaging capable of passing a 1.2 meter drop test has sufficiently demonstrated it can withstand normal transportation conditions. The commenter states this requirement would impose unnecessary costs on clinical laboratories with no safety benefit. We disagree. As indicated above, Category B packagings must be capable of passing a drop test, but need not be capable of passing a puncture or other performance test. A requirement for a rigid outer packaging will help to ensure that the entire package can withstand punctures and other conditions that may be encountered during transportation and particularly at package sorting facilities. In addition, a rigid outer packaging will help to ensure that package markings are intact and legible in the event the package is damaged during transportation. We therefore find the safety benefits of a requirement for a rigid outer packaging outweigh the minimal additional cost of such packaging. However, we do agree a rigid packaging conforming to HMR requirements may be placed inside an envelope or other non-rigid overpack conforming with Sec. 173.25 of the HMR. The commenter (ACLA) also asks us to provide guidance concerning what constitutes a rigid outer packaging. An outer packaging is defined under Sec. 171.8 as the outermost enclosure of a composite or combination packaging together with any absorbent materials, cushioning, and any other components necessary to contain and protect inner receptacles or inner packagings. A rigid packaging is sufficiently stiff and unyielding so as to retain its original shape and dimensions at all times and under all conditions of transportation. Current HMR requirements require infectious substances packed with materials intended to stabilize or prevent degradation of the sample to be transported in accordance with provisions applicable to the hazard class of the stabilizing material used. In the NPRM, we proposed to relax this requirement to except Packing Group II or III materials used to stabilize or prevent degradation of infectious materials up to a limit of 30 mL (1 ounce) or 30 g (1 ounce) in each inner packaging from HMR requirements. A commenter (ACLA) suggests we permit each inner packaging to contain up to 250 mL (25% of the total permitted volume of liquid material per primary receptacle) of Packing Group II or III material. We disagree. For shipments by air, the maximum quantity contained in each inner receptacle of the package may not exceed 1 L; the maximum quantity contained in each outer package may not exceed 4 L. Thus, the revision proposed by ACLA would permit as much as 1 L of a stabilizing material or preservative to be transported in a single package with no additional packaging or hazard communication requirements. Particularly for shipments transported by aircraft, we believe quantities of Packing Group II or III materials in excess of 30 mL pose a sufficient hazard as to require at least minimal regulation. The limit of 30 mL per inner receptacle is consistent with the small quantity exception in Sec. 173.4, which excepts small quantities (up to 30 mL or 30 g per inner receptacle) of certain hazard materials from all HMR requirements provided minimal packaging requirements are met. Moreover, the triple packaging design for infectious substances is similar to the minimal packaging authorized for small quantities of hazardous materials under Sec. 173.4. Thus, we are adopting the limitation on the quantity of preservative permitted in each inner packaging as proposed in the NPRM. If a shipper elects to use a larger quantity of preservative, the shipment must conform to HMR requirements applicable to the specific material and quantity being shipped. Two commenters (Escott, JBM) asked us to clarify that the requirement for a pressure differential test for packagings used to transport Category B infectious substances applies only to transportation by aircraft. As discussed in the NPRM, this provision in existing Sec. 173.199(b)(4) is not changed in this final rule. Either the primary or secondary receptacle for a liquid Category B infectious substance must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of 95 kPa (0.95 bar, 14 psi) when offered or intended for transport by aircraft. C. Emergency Contact Information for Category B Infectious Substances Currently, the HMR require packages of Risk Group 2 and 3 infectious substances (most of which will be classed as Category B infectious substances under this final rule) to be accompanied by shipping papers that include a telephone number that is monitored at all times the hazardous material is in transportation; the telephone number must be the number of a person who is knowledgeable about the hazardous material being shipped and has comprehensive emergency response and incident mitigation information for that material (see Sec. 172.604). Because Category B infectious substances are excepted from shipping paper requirements, in the May 9, 2005 NPRM, we proposed to require the proper shipping name; UN number; and name, address, and telephone number of a person knowledgeable about the material to be provided on a written document, such as an air waybill, accompanying a Category B infectious substance shipment or on the package itself. Two commenters object to the requirement for a contact telephone number. One commenter (Escott) suggests the expense of monitoring the number while the shipment is in transit would impose a significant cost burden on clinical laboratories, medical facilities, and other infectious substance shippers. A second commenter (JBM) suggests the address on the packaging should be sufficient for contacting the responsible party in the event of an incident. This provision to add the emergency contact name and telephone number for Category B infectious substances is intended to harmonize hazard communication for these materials with requirements in the 2005- 2006 ICAO Technical Instructions. The number need not be monitored at all times the hazardous material is in transportation, as would be required under Sec. 172.604 of the HMR. However, we do intend it to be monitored during a company's administrative office hours. Thus, we expect the burden of complying with this requirement will be minimal. Consistent with revisions adopted by ICAO in November 2005, in this final rule, we are not requiring an address as part of the contact information. Emergency contact information shown on a shipping document or on the package must include the name and telephone number of a person knowledgeable about the shipment. We disagree that the number should not be required. Having access to a telephone number will enable transport workers and emergency responders to contact a person knowledgeable about the shipment within a reasonable period of time and, thus, will facilitate the retrieval of information concerning the material and its potential hazards. D. Exceptions for Certain Shipments The HMR currently except certain shipments of infectious substances from all regulatory requirements when the shipments are transported by a private [[Page 32248]] or contract carrier in a motor vehicle used exclusively to transport these materials. In the NPRM, we propose to expand this exception to Category B infectious substances transported for research, diagnosis, investigational activities, or disease treatment or prevention. One commenter (Escott) recommends the HMR include minimal packaging requirements for such shipments, such as non-specification triple packagings with absorbent material, and minimal marking and labeling requirements. Escott states, ``When I worked in a hospital, I received specimens that were transported by a courier and were leaking * * *'' We do not agree Category B shipments transported by private or contract carriers should be regulated under the HMR. We do not have reports of safety problems involving courier shipments of infectious materials under the exception currently provided in the HMR. Courier shipments typically are packaged in primary receptacles, sealed in leak-proof plastic bags, and placed in a leak proof outer container that includes cushioning material. 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 handling potentially infectious materials. Requiring additional packaging and hazard communication requirements would add to the cost of shipping such materials without improving safety. Therefore, we are adopting the exception as proposed in the NPRM. In the NPRM, we indicated the HMR do not apply to a human or animal sample transported for routine testing when the testing is not related to the diagnosis of an infectious disease and when there is no reason to suspect the sample is infectious. Routine screening tests include: (1) Blood or urine tests a doctor may order as part of a routine medical examination to monitor cholesterol levels, blood glucose levels, hormone levels, or prostate specific antibodies (PSA); (2) blood or urine tests to monitor liver or kidney functions in individuals who are not known to have an infectious disease and who are following a particular drug therapy regime; (3) blood or urine tests conducted for insurance or employment purposes and/or intended to determine the presence of alcohol or drugs; (4) DNA tests; and (5) pregnancy tests. Routine tests for diagnoses for other than the presence of pathogens include biopsies to detect cancer and antibody titre testing. This exception proposed in the NPRM is consistent with exceptions adopted in the UN Recommendations for substances unlikely to cause disease in humans or animals, and substances for which there is a low probability an infectious pathogen is present. Three of the four commenters addressing this issue (ACLA, Alcoa, ABC), support the exception from the HMR for transporting specimens from apparently healthy individuals and animals for routine diagnostic testing for other than an infectious disease. These commenters state many years of experience shows the probability of such samples being infectious is low, and, therefore, their transportation is unlikely to compromise safety. These commenters also state permitting the transportation of samples from apparently healthy individuals for routine testing will facilitate the processing of such samples and initiation of appropriate patient treatment. One commenter (JBM) opposes the exception. The commenter suggests samples from apparently healthy individuals may contain pathogens and recommends minimal packaging standards to guard against the release of the sample during transportation. We agree with the commenters who suggest that samples from apparently healthy individuals and animals being transported for routine testing unrelated to the diagnosis of an infectious disease are not likely to be infectious and, thus, pose a minimal safety risk. Patient specimens excepted from regulation under the HMR are those from persons believed by professional judgment to have a minimal likelihood of harboring an infectious agent. These specimens typically are blood, serum, urine, stool, biopsies, hair, finger or toe nails, semen, or other similar samples from a body. According to health care specialists and scientists at WHO and the U.S. Department of Health and Human Services, the risk of infection during transportation from samples taken from apparently healthy patients and animals and transported for routine testing is extremely small. Therefore, we are adopting the exception from HMR requirements for such samples as proposed in the NPRM. Shippers and carriers should be aware ICAO has adopted minimal standards applicable to the transportation of human or animal specimens for which there is minimal likelihood that pathogens are present. Such specimens are not subject to ICAO requirements when they are transported in a packaging designed to prevent any leakage and marked with the words ``Exempt human specimen'' or ``Exempt animal specimen,'' as applicable. This is a mandatory ICAO requirement; however, we are not adopting it in this final rule. Such samples are not transported in a quantity or form that poses an unreasonable risk to health and safety. Thus, for purposes of the HMR, such specimens are not considered hazardous materials and are not subject to any requirements. Note that use of the ``Exempt human specimen'' or ``Exempt animal specimen'' marks by a shipper indicates that the relevant packages do not contain a hazardous material. Therefore, packages bearing these marks may be accepted by air carriers making a business decision to not accept hazardous materials. Conversely, packages bearing the Proper Shipping Names ``Infectious Substance, affecting humans'' or ``Infectious Substance, affecting animals'' or ``Biological Substance, Category B'' must be rejected by air carriers making a business decision to not accept hazardous materials. E. Notification to Pilot-in-Command Generally, a notification to the pilot-in-command (NOPIC) is required for shipments of hazardous materials subject to the HMR or ICAO Technical Instructions. The NOPIC includes the proper shipping name, hazard class, and identification number of the hazardous material; the total number of packages; the net quantity or gross weight for each package; the location of the packages on the aircraft; any additional information required by the regulations; and confirmation that no damaged or leaking packages have been loaded on the aircraft (see Sec. 175.33 of the HMR and Chapter 4, paragraph 4.1.1, and Chapter 7, paragraph 7.4.1 of the ICAO Technical Instructions). The NOPIC provides the pilot-in-command with information to make critical decisions and take necessary safety precautions in the event of an emergency on board the aircraft.?> In the preamble to the NPRM, we indicated, consistent with the ICAO Technical Instructions, we were not proposing to require a NOPIC for air shipments of Category B infectious substances. We noted that ICAO narrowly decided against such a requirement for the 2005-2006 Edition of the ICAO Technical Instruction. ICAO members opposed to the requirement cited the low risk in transportation associated with Category B infectious substances, new ICAO requirements for hazard communication for Category B shipments, and the possibility that increased regulation would result in fewer carriers electing to transport Category B shipments. Members supporting the NOPIC [[Page 32249]] requirement cited the benefit of information being available to the pilot and emergency responders in the event of an emergency or an accident. We invited commenters to address this issue, and whether or not the HMR should require a NOPIC for shipments of Category B infectious substances. Of the three commenters who address this issue, two (ATA, ACLA) support the ICAO decision to not require a NOPIC for Category B infectious substances. These commenters note Category B infectious substances pose a reduced risk in transportation because they do not cause permanent disability or life-threatening or fatal disease to humans or animals. These commenters agree the hazard communication requirements in the ICAO Technical Instruction provide sufficient information for package handlers and emergency responders to make necessary safety decisions in the event of an emergency. The commenters also state the NOPIC provision would increase administrative and training costs and could result in the refusal by some carriers to transport these materials. The ultimate impact of a NOPIC provision in the HMR, according to these commenters, could be to impede or delay transportation of Category B infectious substances. One commenter (ALPA) supports a requirement for a NOPIC for shipments of Category B infectious substances. This commenter suggests a NOPIC is necessary to enable transport workers to make informed judgments concerning the segregation and loading of packages and enhances the ability of the pilot in command to make potentially life- saving decisions concerning the occupants of his or her aircraft and to advise emergency personnel. As indicated above, Category B infectious materials pose a reduced risk in transportation because they do not cause life-threatening or fatal disease in otherwise healthy humans or animals. The hazard communication requirements adopted in this final rule are adequate to assure transport workers exercise care in handling packages of Category B materials and protect themselves if they discover a damaged or leaking package. We agree with commenters who suggest the impact of requiring a NOPIC for shipments of Category B infectious materials would be to impede or delay transportation of these shipments; such delays could adversely affect patient treatment and public health. Therefore, we are not adopting a requirement for a NOPIC for shipments of Category B infectious substances in this final rule. F. Regulated Medical Waste The HMR currently define regulated medical waste (RMW) to mean a waste or reusable material known to contain or suspected to contain an infectious substance in Risk Group 2 or 3, and generated in the diagnosis, treatment, or immunization of human beings or animals; research on the diagnosis, treatment, or immunization of human beings or animals; or the production or testing of biological products. In the NPRM, we proposed to revise this definition to mean a waste or reusable material known to contain or suspected to contain a Category B infectious substance. In accordance with the definition proposed in the NPRM, RMW containing a Category A infectious substance must be classed as Division 6.2, described as an infectious substance affecting humans or affecting animals only, as appropriate, assigned to UN 2814 or UN 2900, and transported in accordance with all applicable requirements. Medical waste containing a Category A infectious substance may not be transported under the shipping name ``Regulated medical waste, n.o.s.,'' UN 3291. Medical waste containing a Category A infectious substance must be described as ``Infectious substances, affecting humans'' or ``Infectious substances, affecting animals,'' assigned to UN 2814 or UN 2900, and packaged in a UN specification packaging conforming to the requirements of Sec. 173.196 of the HMR. Infectious medical waste containing a Category A infectious substance is not excepted from regulation under 173.134(c) of the HMR when transported by private or contract carriers. One commenter (Stericycle) expresses concern about the NPRM's treatment of RMW containing a Category A infectious substance, suggesting the proposals could be confusing for facilities generating RMW and the carriers transporting them. The commenter asks us to consider permitting RMW containing a Category A infectious substance to be transported as ``Regulated medical waste, n.o.s.,'' UN 3291, noting that about one-half of the materials listed in the preamble to the NPRM as Category A infectious materials are currently assigned to Risk Group 2 or 3 materials permitted to be transported as RMW under UN 3291. The requirements adopted in this final rule for the transportation of RMW containing a Category A infectious substance are the same as the current HMR requirements for the transportation of RMW containing a Risk Group 4 infectious substance. A Category A infectious substance is one transported in a form capable of causing permanent disability or life-threatening or fatal disease to an otherwise healthy human or animal when exposure to it occurs. Certain Category B infectious substances in culture form pose a significant risk in transportation and were added to the Category A list under the regulations of the UN Recommendations, ICAO Technical Instructions, and the IMDG Code. We have adopted this provision as proposed in the NPRM to harmonize with these requirements. As Stericycle notes, a number of the infectious agents on the list of Category A infectious substances are currently considered Risk Group 2 or 3 materials. However, they are included on the Category A list only as cultures--that is, when the pathogen is intentionally propagated. Most cultured infectious substances are not transported for disposal, but are destroyed or rendered non-infectious onsite. In all other forms, these materials are considered Category B infectious substances and may be transported as ``Regulated medical waste, n.o.s.,'' UN 3291. Requiring infectious medical waste containing a Category A infectious substance to be transported as an infectious substance, UN 2814 or 2900, appropriately addresses the risks posed by these materials. Therefore, we are adopting the requirements applicable to the transportation of RMW as proposed in the NPRM. RMW containing a Category A infectious substance should be handled and managed at medical facilities in the same manner as RMW containing a Risk Group 4 infectious substance is currently handled. G. Sharps Containers As currently required under the HMR, sharps containers generally must comply with Sec. 173.197, which requires sharps to be in a UN specification packaging that is puncture resistant for sharps and sharps with residual fluid, as demonstrated by conformance with the design and test requirements in subpart M of part 178 at the Packing Group II performance level. The performance tests must be conducted with the packaging assembled as if for transportation, including with the closure secured as it would be for transportation. A sharps container that conforms to the","truncated":true,"body_characters":124572}