# Hazardous Materials: Infectious Substances; Harmonization With the United Nations Recommendations

- **operation:** document
- **citation:** 70 FR 29170
- **title:** Hazardous Materials: Infectious Substances; Harmonization With the United Nations Recommendations
- **source type:** rulemaking
- **agency:** Pipeline and Hazardous Materials Safety Administration
- **status:** proposed
- **official:** true
- **published on:** 2005-05-19
- **effective on:** Not available
- **summary:** PHMSA is proposing to revise the transportation requirements for infectious substances, including regulated medical waste, to adopt new classification criteria and packaging requirements consistent with revised international standards and to clarify existing requirements to promote compliance. These proposed revisions will ensure an acceptable level of safety for the transportation of infectious substances and facilitate domestic and international transportation.
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- **source url:** https://www.federalregister.gov/documents/2005/05/19/05-9717/hazardous-materials-infectious-substances-harmonization-with-the-united-nations-recommendations
**body:**

Federal Register, Volume 70 Issue 96 (Thursday, May 19, 2005) [Federal Register Volume 70, Number 96 (Thursday, May 19, 2005)] [Proposed Rules] [Pages 29170-29187] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 05-9717] [[Page 29169]] ----------------------------------------------------------------------- Part VII Department of Transportation ----------------------------------------------------------------------- Pipeline and Hazardous Materials Safety Administration ----------------------------------------------------------------------- 49 CFR Parts 171, 172, 173, 175 Hazardous Materials: Infectious Substances; Harmonization With the United Nations Recommendations; Proposed Rule Federal Register / Vol. 70, No. 96 / Thursday, May 19, 2005 / Proposed Rules [[Page 29170]] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts 171, 172, 173, 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: Notice of proposed rulemaking (NPRM). ----------------------------------------------------------------------- SUMMARY: PHMSA is proposing to revise the transportation requirements for infectious substances, including regulated medical waste, to adopt new classification criteria and packaging requirements consistent with revised international standards and to clarify existing requirements to promote compliance. These proposed revisions will ensure an acceptable level of safety for the transportation of infectious substances and facilitate domestic and international transportation. DATES: Comments must be received by July 18, 2005. ADDRESSES: You may submit comments by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov . Follow the online instructions for submitting comments. Web Site: http://dms.dot.gov . Follow the instructions for submitting comments on the DOT electronic docket site. You may view the public docket through the Internet at http://dms.dot.gov or in person at the Docket Management System office at the above address. Fax: 1-202-493-2251 Mail: Docket Management System, U.S. Department of Transportation, 400 Seventh Street, SW., Nassif Building, Room PL-401, Washington, DC 20590-0001. Hand Delivery: To the Dockets Management System; Room PL-401 on the plaza level of the Nassif Building, 400 Seventh Street, SW., Washington, DC between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Instructions: You must include the agency name (Pipeline and Hazardous Materials Safety Administration) and docket number (PHMSA- 2004-16895 (HM-226A)) or the Regulatory Identification Number (RIN) for this notice at the beginning of your comments. You should submit two copies of your comments if you submit them by mail. If you wish to receive confirmation that we received your comments, you must include a self-addressed stamped postcard. Note that all comments received will be posted without change to `` http://dms.dot.gov '', including any personal information provided, and will be accessible to Internet users. Please see the Privacy Act section of this document. FOR FURTHER INFORMATION CONTACT: Eileen Edmonson or Deborah Boothe, Office of Hazardous Materials Standards, (202) 366-8553, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation. SUPPLEMENTARY INFORMATION: I. Background On August 14, 2002, the Research and Special Programs Administration (RSPA), the predecessor agency to the Pipeline and Hazardous Materials Safety Administration (PHMSA), published a final rule revising the requirements in the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of infectious substances, including regulated medical waste (67 FR 53118). The final rule made the following changes to the HMR: Adopted new classification criteria for infectious substances based on defining criteria developed by the World Health Organization (WHO) and consistent with standards contained in the 12th Revised Edition of the United Nations Recommendations on the Transport of Dangerous Goods (UN Recommendations) and the 2003-2004 Edition of the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions). Revised packaging requirements for Division 6.2 materials for consistency with international performance standards. Eliminated an exception from requirements in the HMR for diagnostic specimens and adopted certain packaging and hazard communication requirements for these materials. Diagnostic specimens transported by private or contract carriers in motor vehicles used exclusively for diagnostic specimens continue to be excepted from most requirements in the HMR. Modified an 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. Adopted bulk packaging options for the transportation of regulated medical waste (RMW), based on exemption provisions. Established new hazard communication requirements for shipments of Division 6.2 materials. The requirements in the August 14, 2002 final rule became effective on February 14, 2003. II. Issues Related to Current Requirements Our August 14, 2002 final rule adopted a risk-group-based classification system for infectious substances based on criteria in the UN Recommendations. The final rule requires 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, [[Page 29171]] transportation problems can delay research necessary to develop treatments or slow the spread of disease, and can interfere with the 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 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. The requirements adopted for the UN Recommendations establish a two-tiered classification system for Division 6.2 materials--Category A and Category B. A Category A infectious substance poses a higher degree of risk than a Category B infectious substance. A Category A material is an infectious substance that is transported in a form that is 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 UN 2814 (for substances that cause disease in humans or in both humans and animals) or UN 2900 (for substances that cause disease in animals only). The following are examples of Category A infectious substances. Please note this list is not all inclusive and is provided only as guidance. ------------------------------------------------------------------------ UN number and proper shipping name Micro-organism ------------------------------------------------------------------------ UN 2814: Infectious substances affecting Bacillus anthracis (cultures only) humans and animals. 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 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 Russian spring-summer encephalitis virus (cultures only) Sabia virus Shigella dysenteriae type I (cultures only) Tick-borne encephalitis virus (cultures only) Variola virus [[Page 29172]] Venezuelan equine encephalitis virus Vesicular stomatitis virus (cultures only) West Nile virus (cultures only) Yellow fever virus (cultures only) Yersinia pestis (cultures only) UN 2900: African swine fever virus (cultures only) Infectious substances affecting Avian paramyxovirus Type 1-- animals only. 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) ------------------------------------------------------------------------ Under the UN Recommendations, Category A infectious substances are packaged in UN specification packagings that consist of a watertight primary receptacle or receptacles; a watertight secondary packaging; for liquid materials, absorbent material in sufficient quantity to absorb the entire contents; and a rigid outer packaging of adequate strength for its capacity, mass, and intended use. The completed packaging must pass specified performance tests, including a drop test and a water-spray test, and must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of not less than 95 kPa (0.95 bar, 14 psi). The completed packaging must also be capable of withstanding, without leakage, temperatures in the range of -40 [deg]C to +55 [deg]C (-40 [deg]F to 131 [deg]F). The completed package must be labeled with a Division 6.2 label and must be accompanied by appropriate shipping documentation. The packaging specified for Category A infectious substances is consistent with the packaging currently required for infectious substances assigned to UN 2814 or UN 2900. 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. The Category A and B designations developed for purposes of transportation are different from the Category A and B designations for agents of bioterrorism developed by the Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH). The critieria for inclusion in these categories differ, and, although there is some overlap, the lists should not be confused. It is extremely important that persons offering infectious materials for transportation in commerce assign infectious substances to the appropriate category to avoid inappropriate packaging for the materials. 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 names ``Diagnostic Specimen'' and ``Clinical Specimen'' in the 13th Edition of the UN Recommendations and in the 2005-2006 ICAO Technical Instructions, and adoption of the proper shipping name ``Diagnostic specimen'' in the HMR have 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. Under the UN Recommendations, a Category B infectious substance is packaged in a packaging consisting of a leakproof primary receptacle, a leakproof secondary packaging, and a rigid outer packaging. At least one surface of the outer packaging must have a minimum dimension of 100 mm by 100 mm (3.9 inches). The packaging must be of good quality and strong enough to withstand the shocks and loadings normally encountered during transportation. For liquid materials, the secondary packaging must contain absorbent material in sufficient quantities to absorb the entire contents of the primary receptacle or receptacles. The primary or secondary packaging must be capable of withstanding, without leakage, an internal pressure producing a pressure differential of 95 kPa. The packaging must be constructed and closed to prevent any loss of contents that might be caused under normal conditions of transportation by vibration or changes in temperature, humidity, or pressure. The completed packaging must be capable of passing a 1.2- meter (3.9 feet) drop test. The package must be marked with a diamond- shaped marking containing the identification number ``UN 3373'' and with the proper shipping name ``Biological substance, Category B.'' The minimum size for the diamond-shaped mark includes sides at least 50 mm (1.97 inches) long, and letters and numbers at least 6 mm (0.24 inches) high. Under the UN Recommendations, shipments of Category B infectious substances are not [[Page 29173]] subject to any other transportation requirements. The 2005-2006 ICAO Technical Instructions, which are based in part on the UN Recommendations, include additional requirements for Category B infectious substances. Specifically, the ICAO Technical Instructions 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, or on the package. Representatives of the United States worked closely with the UN Committee of Experts and the ICAO Dangerous Goods Panel to develop the revised requirements for transporting infectious substances. The new requirements are based on a scientific evaluation of the real risks that these materials pose in transportation. Category B infectious substances pose a reduced risk of infection upon exposure based on the way they are transmitted (route of infection) and the number of pathogens required to initiate an infection. Certain infectious substances previously assigned to Risk Group 2 or 3 substances are now assigned to Category B infectious substances and are subject to less stringent regulatory requirements. The Category B packaging provides triple barriers and absorbent and cushioning materials that are designed to prevent leakage of the material during transportation. We believe that the regulations developed for the 13th and 14th Revised Editions of the UN Recommendations provide a less confusing and more appropriate regulatory system than the current risk-group-based system. Therefore, in this NPRM, we are proposing to harmonize the HMR requirements for the transportation of infectious substances with those adopted or expected to be adopted for the UN Recommendations and the ICAO Technical Instructions. Specific regulatory proposals are discussed in the ``Section-by- Section Review'' section of this preamble. III. Category A Versus Risk Group 4 Classification As indicated above, the HMR currently require Division 6.2 materials to be assigned to one of four risk groups based on the degree of risk associated with laboratory manipulation of the pathogen. A Risk Group 4 pathogen is one that usually causes serious human or animal disease and that can be readily transmitted from one individual to another, directly or indirectly, and for which effective treatments and preventive measures are not usually available. A Category A material is an infectious substance that is transported in a form that is capable of causing permanent disability or life-threatening or fatal disease to humans or animals when exposure to it occurs. As the guidance earlier in this document suggests, this new definition may include cultures of materials that previously were considered Risk Group 2 and 3 materials. The transportation requirements for Category A infectious substances are identical to current requirements under both the HMR and the UN Recommendations for Risk Group 4 infectious substances. The HMR currently provide for exceptions from certain regulatory requirements for Risk Group 2 or 3 infectious substances; however, these exceptions may not be used for Risk Group 4 materials. For example, the HMR currently permit diagnostic specimens, biological products, and regulated medical waste (RMW) that contain Risk Group 2 or 3 infectious substances to be transported as materials of trade (MOTS) in accordance with Sec. 173.6. The MOTS exception may not be used to transport Risk Group 4 materials. In this NPRM, we propose to limit exceptions authorized for the transportation of infectious substances to Category B materials; thus, Category A materials could not be shipped as MOTS. We recognize that this approach somewhat narrows the applicability of the transportation exceptions that are currently permitted under the HMR. In particular, we note that, as proposed in this NPRM, RMW that contains a Category A infectious substance must be transported in accordance with requirements applicable to UN 2814 (infectious substance affecting humans) or UN 2900 (infectious substance affecting animals only) rather than UN 3291 (regulated medical waste). We believe the proposed amendments accurately address the risks posed by these materials; however, we invite commenters to address the transportation impacts, if any, of the proposed revisions. IV. Notification to Pilot-in-Command As noted earlier, the proposals in this NPRM are consistent with standards adopted by the UN and ICAO. A major issue associated with ICAO's adoption of the provisions applicable to infectious substances in the 13th Revised Edition of the UN Recommendations was whether or not to require notification to the pilot-in-command (NOPIC) of an aircraft of the presence of Category B infectious substances as cargo on board the aircraft. Under the standards adopted for the UN Recommendations, Category B infectious substances are not accompanied by shipping papers nor must their packages be labeled. The hazard communication required for a package containing a Category B infectious substance is a package marking consisting of ``UN 3373'' in a square- on-point configuration and the words ``Biological substance, Category B'' in association with the UN number. ICAO adopted additional hazard communication requirements for Category B infectious substances. Specifically, the ICAO Technical Instructions 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) or on the package itself. As noted above, we propose to adopt the ICAO requirements into the HMR for air transportation. Generally, a 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. ICAO narrowly decided against requiring a NOPIC for shipments of Category B infectious substances for the 2005-2006 Edition of the ICAO Technical Instructions. The ICAO vote on the issue was evenly split; an equal number supported a requirement for a NOPIC for Category B infectious substances as opposed the requirement. 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 requirement cited the benefit of information being available to the pilot and emergency responders in the event of an emergency or an accident. Consistent with the ICAO decision, this [[Page 29174]] NPRM does not propose to require a NOPIC for Category B infectious substances. However, we invite commenters to address this issue. Should the HMR require a NOPIC for shipments of Category B infectious substances? What would be the benefits or adverse impacts of such a requirement? V. Transportation of Unknown or Suspected Infectious Substances The public health community is frequently confronted with outbreaks of disease of unknown etiology and must quickly transport specimens for identification and diagnosis. This rulemaking proposes that, generally, routine samples that are unlikely to contain an infectious substance or where the pathogenicity of the infectious substance is at a level naturally encountered in the environment that will not cause disease when exposure to it occurs may be transported as non-regulated materials. In most other cases, this rulemaking proposes to permit unknown samples shipped for analysis and diagnosis to be transported in accordance with requirements for Category B infectious substances, because, historically, materials meeting this definition have been transported in a similar manner with no adverse safety impact or increased risk to transport workers or the general public. For situations where the identity of the agent or pathogen is not known, but sufficient information is available to strongly suspect a Category A infectious substance, this NPRM proposes to require an indication on shipping papers that the sample contains a Category A infectious material, as follows--``Infectious substances, affecting humans (suspected Category A infectious substance), 6.2, UN 2814''. Suspected Category A infectious substances must be shipped in accordance with all applicable hazard communication and packaging requirements for Category A infectious substances. The determination as to whether to ship an unknown sample as a Category A or Category B infectious substance should be made by appropriate medical or public health officials based on known medical conditions and history of the source patient or animal, endemic local conditions, and symptoms of the source patient or animal. VI. Security Requirements for Select Agents Currently, persons who offer for transportation or transport certain infectious substances in commerce must develop and implement security plans in accordance with Subpart I of Part 172 of the HMR. Specific measures implemented as part of the plan may vary commensurate with the level of threat at a particular time. At a minimum, the security plan must address personnel security, unauthorized access, and en route security. For personnel security, the plan must include measures to confirm information provided by job applicants for positions that involve access to and handling of the hazardous materials covered by the plan. For unauthorized access, the plan must include measures to address the risk that unauthorized persons may gain access to materials or transport conveyances being prepared for transportation. For en route security, the plan must include measures to address security risks during transportation, including shipments stored temporarily en route to their destinations. For infectious substances, the security plan requirements apply to shipments of select agents and toxins regulated by CDC under 42 CFR Part 73. The CDC regulations identify select agents and toxins affecting humans (``HHS Select Agents and Toxins'') and select agents and toxins affecting both humans and animals (``Overlap Select Agents and Toxins''). The USDA regulations at 9 CFR Part 121 identify select agents and toxins affecting animals, in addition to the Overlap Select Agents and Toxins that are also listed in the CDC regulations. USDA regulations at 7 CFR Part 331 identify agents and toxins affecting plants. Select agents and toxins affecting animals only are not currently subject to the security plan requirements. Biological agents and toxins affecting plants only do not meet the definition of an infectious substance under the HMR. CDC and USDA regulate select agents and toxins because they have the potential to pose a severe threat to the public health and safety. Select agents and toxins affecting animals could be used to compromise public health; therefore, in this NPRM we propose to add the select agents and toxins listed in 9 CFR Part 121 to the list of hazardous materials for which security plans are required. As proposed, persons who offer or transport any of the materials regulated under 9 CFR Part 121 would be required to develop and implement security plans that conform to HMR requirements. We propose to provide six months from the effective date of a final rule for shippers and carriers to come into compliance with this new requirement. We invite commenters to address whether we should also require persons who offer or transport select agents and toxins that have been found to pose a severe threat to plant health or plant products, regulated by USDA under 7 CFR Part 331, to develop and implement transportation security plans. Such materials could also be used illegitimately to compromise public health. VII. Sharps Containers There appears to be some confusion in the regulated community about HMR requirements applicable to sharps containers. The current requirements appear in several places in the regulations. For non-bulk shipments, a sharps container must be a UN specification packaging that is puncture resistant for sharps and sharps with residual fluid as demonstrated by conformance to the design and test requirements in Subpart M of Part 178 at the Packing Group II performance level. A sharps container that conforms to these requirements need not be placed in an outer packaging for transport. A sharps container placed inside a bulk packaging, such as a UN specification Large Packaging or a non- specification bulk outer packaging or wheeled cart, must be puncture resistant. A sharps container that is 20 gallons or less in volume need not be a UN specification packaging if it is to be placed in a bulk outer packaging. A sharps container that is larger than 20 gallons in volume that is placed inside a bulk packaging must be capable of passing the performance tests in Subpart M of Part 178 at the Packing Group II performance level. A sharps container that will be placed in a bulk outer packaging for transportation may be reused only if it is specifically cleared or approved by FDA as a medical device for reuse and must have a capacity of between 2 and 40 gallons. The HMR include an exception from certain requirements for regulated medical waste (RMW), including sharps, transported by a private or contract carriers (see Sec. 173.134(c)). Under this exception, RMW, including sharps, may be transported in a rigid, non- bulk packaging that conforms to the general packaging requirements of Sec. Sec. 173.24 and 173.24a and packaging requirements specified in OSHA standards at 29 CFR 1910.1030. The packaging requirements in Sec. Sec. 173.24 and 173.24a address general packaging issues such as packaging integrity, filling limits, and closures. Specifically with regard to leakproofness, Sec. 173.24(f) requires closures to be leakproof and secured against loosening. The OSHA standards at 29 CFR 1910.1030 require sharps containers to be puncture [[Page 29175]] resistant and leakproof (see 1910.1030(d)(4)(iii)(A)(1)). Our enforcement experience indicates that the closures currently being used for sharps containers may not adequately assure that no contents will be released during transportation. Therefore, in this NPRM, we proposed to add specific closure requirements in a number of sections applicable to the transportation of RMW, including sharps. In addition, we invite commenters to consider whether the requirements for sharps containers should be modified. In this regard, we note that certain sharps containers are regulated as medical devices subject to pre-market review by FDA. FDA's pre-market review seeks primarily to address sharps containment in hospital and laboratory settings, not for transportation. It is our understanding, therefore, that sharps containers cleared or approved by FDA may not meet the HMR requirements in Sec. Sec. 173.197(b) and 173.134(c). For example, FDA reviews marketing applications for sharps containers to determine, among other things, whether they are leak resistant on the sides and bottoms and closures are leak resistant. This is a lesser standard than the leakproofness standard established in the HMR. We ask commenters to address whether the HMR should permit FDA-cleared or -approved sharps containers to be used for the transportation of sharps and, if so, under what circumstances. For example, we could permit FDA-cleared or - approved sharps containers to be used for the transportation of sharps provided such containers are placed inside a leakproof outer packaging. VIII. Incident Reporting Since February 14, 2003 Under the final rule adopted under Docket HM-226, effective February 14, 2003, air carriers are required to report incidents involving diagnostic specimens in accordance with the incident reporting requirements in Sec. Sec. 171.15 and 171.16. We conducted a review of incidents involving diagnostic specimens in air transportation. We found that 133 air transport incidents were reported between March and June 2004. Prior to March 2004, carriers reported very few incidents. (A chart summarizing the reported incidents and a detailed listing of the incident reports is included in the docket for this rulemaking.) An analysis of the detailed incident reports indicates that in almost all cases the packages that leaked were not prepared in accordance with the requirements of Sec. 173.199. For example, many of the reported incidents appear to have resulted from improper closure of either the primary receptacle or the secondary packaging. Other packagings involved in reported incidents did not include absorbent or cushioning material. Our analysis does not show a trend in package failures that would indicate a problem with the adequacy of the packaging currently authorized by the HMR for the transportation of diagnostic specimens and proposed in this NPRM to be authorized for the transportation of Category B infectious substances. Rather, our analysis indicates that some shippers do not understand the regulatory requirements in Sec. 173.199. To address this problem, in this NPRM we propose to require the manufacturer and subsequent distributors of packagings authorized for the transportation of Category B infectious substances under Sec. 173.199 to provide clear instructions on filling, preparing, and closing the packaging to the consignor or the person who prepares the package for transportation. In this regard, we note that a number of testing laboratories provide the packaging for patients or health care professionals to use in transporting patient samples for testing and diagnosis. Under this NPRM, the proposed requirement to provide clear filling and closure instructions would apply to such testing laboratories as ``subsequent distributors'' of the packaging. It is also important to note that selection of an appropriate packaging for the transportation of a hazardous material is a regulated pre-transportation function under the HMR. Thus, the entity providing the packaging could be subject to enforcement action as an offeror of the infectious substance if the packaging does not comply with applicable HMR requirements. We have prepared a guidance document addressing the current requirements in the HMR for proper classification and packaging for diagnostic specimens which is available from our Office of Hazardous Materials Initiatives and Training at (202) 366-4900 or online at http://hazmat.dot.gov/InfectSubstances.pdf . IX. Section-by-Section Review This section-by-section review summarizes the proposed changes believed to be most important, and requests additional comments in some sections. Part 171 Section 171.8. In Sec. 171.8, we propose to remove the definition for Risk Group. Part 172 Section 172.101. In the Hazardous Materials Table, we are proposing several revisions. Most importantly, we are removing the current entry for ``Diagnostic Specimens'' for consistency with amendments expected to be adopted for the 14th Revised Edition of the UN Recommendations. We are adding an entry for ``Biological substance, Category B.'' This entry will apply to shipments of Category B infectious substances, which must be classed as Division 6.2, described as a ``Biological substances, Category B,'' and assigned to UN 3373. In addition, we propose to revise the entries for ``Infectious substances, affecting animals'' and ``Infectious substances, affecting humans'' to delete Special Provision A81 (see discussion below). Further, for consistency with the UN Recommendations, we propose to revise the two entries for toxins to include the phrase ``extracted from living sources.'' Section 172.102. We are proposing to remove Special Provision A81, which permits the quantity limits currently specified in the HMT for air shipments to be exceeded for shipments of body fluids packaged in accordance with Sec. 173.196. This special provision is no longer necessary because of the changes we propose applicable to shipments of Category B infectious substances. We propose to include quantity limits for air transportation in Sec. 173.199. Section 172.200. Consistent with requirements in the ICAO Technical Instructions, in Sec. 172.200 we are proposing to clarify that the shipping paper requirements do not apply to Category B infectious substances prepared in accordance with Sec. 173.199 of the HMR. This proposal is consistent with the requirements adopted for the UN Recommendations, which except Category B infectious substances from the shipping paper requirements of Part 172. Section 172.203. In paragraph (k) of Sec. 172.203, we propose to authorize a shipping paper that accompanies a shipment of a suspected Category A infectious substance to include the words ``suspected Category A infectious substance'' in parentheses as an alternative to a technical name that describes the pathogen(s) it contains when the infectious substance is not known. Thus, the shipping description for a suspected Category A infectious substance affecting humans would read, ``Infectious substa
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