{"operation":"document","citation":"63 FR 46844","title":"Hazardous Materials: Revision to Standards for Infectious Substances and Genetically Modified Micro-organisms","source_type":"rulemaking","agency":"Research and Special Programs Administration","status":"proposed","official":true,"published_on":"1998-09-02","effective_on":null,"summary":"RSPA is considering revising the requirements for infectious substances, including regulated medical waste (RMW) to: adopt defining criteria, hazard communication and packaging requirements for Division 6.2 materials consistent with international standards; revise broad exceptions for diagnostic specimens and biological products; provide additional packagings for RMW; and make other changes to improve and clarify regulatory requirements and exceptions. These proposals are intended to ensure an acceptable level of safety in the transport of infectious substances, facilitate international transportation and make it easier to understand and comply with the regulations. In order to enhance the opportunity to provide comments to RSPA concerning this notice, the public is invited to provide written or E- mail comments during the comment period and to participate in an electronic public meeting on the Internet on September 14, 15 and 16, 1998.","machine_formats":{"json":"https://regulus.evalyn.ai/document/federal-register-98-23665.json","markdown":"https://regulus.evalyn.ai/document/federal-register-98-23665.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-98-23665","source_url":"https://www.federalregister.gov/documents/1998/09/02/98-23665/hazardous-materials-revision-to-standards-for-infectious-substances-and-genetically-modified","body":"Federal Register, Volume 63 Issue 170 (Wednesday, September 2, 1998) [Federal Register Volume 63, Number 170 (Wednesday, September 2, 1998)] [Proposed Rules] [Pages 46844-46859] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 98-23665] [[Page 46843]] _______________________________________________________________________ Part IV Department of Transportation _______________________________________________________________________ Research and Special Programs Administration _______________________________________________________________________ 49 CFR Part 171, et al. Hazardous Materials: Revision to Standards for Infectious Substances and Genetically Modified Micro-organisms; Proposed Rule Federal Register / Vol. 63, No. 170 / Wednesday, September 2, 1998 / Proposed Rules [[Page 46844]] DEPARTMENT OF TRANSPORTATION Research and Special Programs Administration 49 CFR Parts 171, 172, 173, and 178 [Docket No. RSPA 98-3971 (HM-226)] RIN 2137-AD13 Hazardous Materials: Revision to Standards for Infectious Substances and Genetically Modified Micro-organisms AGENCY: Research and Special Programs Administration (RSPA), DOT. ACTION: Advance notice of proposed rulemaking (ANPRM); notice of public meeting. ----------------------------------------------------------------------- SUMMARY: RSPA is considering revising the requirements for infectious substances, including regulated medical waste (RMW) to: adopt defining criteria, hazard communication and packaging requirements for Division 6.2 materials consistent with international standards; revise broad exceptions for diagnostic specimens and biological products; provide additional packagings for RMW; and make other changes to improve and clarify regulatory requirements and exceptions. These proposals are intended to ensure an acceptable level of safety in the transport of infectious substances, facilitate international transportation and make it easier to understand and comply with the regulations. In order to enhance the opportunity to provide comments to RSPA concerning this notice, the public is invited to provide written or E- mail comments during the comment period and to participate in an electronic public meeting on the Internet on September 14, 15 and 16, 1998. DATES: Comment date: Comments must be submitted on or before December 1, 1998. Electronic public meeting date: The electronic public meeting will commence on September 14, 1998, at 9:00 a.m. and end on September 16, 1998 at 12 noon (Eastern Daylight Time). ADDRESSES: Information on the electronic meeting, including the Internet address, is available under SUPPLEMENTARY INFORMATION. Written comments: Address written comments to the Dockets Management System, U.S. Department of Transportation, Room PL-401, 400 Seventh Street, SW, Washington, DC 20590-0001. Comments should identify the docket number (Docket Number RSPA-98-3971). Persons wishing to receive confirmation of receipt of their comments should include a self-addressed, stamped postcard. Comments may also be submitted by E-mail to `` [email protected] ''. Dockets Management System is located on the Plaza Level of the Nassif Building at the Department of Transportation at the above address. Public dockets may be reviewed there between the hours of 10:00 a.m. and 5:00 p.m., Monday through Friday, except Federal holidays. In addition, the public may also review comments by accessing the docket management system through the DOT home page ( http:// dms.dot.gov ). An electronic copy of the document may be downloaded using a modem and suitable communications software from the Government Printing Office Electronic Bulletin Board Service at (202) 512-1661. FOR FURTHER INFORMATION CONTACT: Eileen Mack, Office of Hazardous Materials Standards, (202) 366-8553, Research and Special Programs Administration, U.S. Department of Transportation, 400 Seventh Street, SW, Washington, DC 20590-0001. SUPPLEMENTARY INFORMATION: Electronic public meeting: The electronic public meeting will be held at the conferences and public meetings section of RSPA's hazmat home page. The Universal Resource Locator (URL) address is `` http://hazmat.dot.gov/forum ''. The electronic meeting will enable anyone with Internet access to participate in a near real-time electronic discussion of the rulemaking. This type of meeting may also increase the breadth of domestic and international participation in the commenting process. The message board will be posted on RSPA's hazmat web site and will be hot-linked to this advance notice of proposed rulemaking. A transcript of the electronic public meeting will be placed in the docket. The topics are as follows: List of Topics I. Background II. Proposed Revisions A. World Health Organization Risk Groups/International Recommendations and Regulations B. Diagnostic Specimens C. Biological Products D. Genetically Modified Organisms and Micro-organisms E. Hazard Communication F. Regulated Medical Waste G. Materials of Trade Exception H. Discussion of Petition for Rulemaking I. Segregation from Foodstuffs I. Background On September 20, 1995, RSPA published a final rule (60 FR 48780) to revise the requirements for Division 6.2 materials (infectious substances). The rule clarified the scope of regulation for infectious substances, provided relief for certain shipments of regulated medical waste (RMW) that conform to other Federal agency regulations, allowed certain quantities of RMW to be transported by aircraft, and made other changes to clarify the regulatory provisions applicable to infectious substances. The final rule was intended to address critical, yet non- controversial, issues. RSPA stated in the final rule that other, more complex issues would be considered in a future rulemaking. This ANPRM seeks comment on RSPA's discussion of certain issues and solicits information to address the agency's concerns for safety in transportation of infectious substances and genetically modified micro- organisms and organisms. II. Revisions Under Consideration A. World Health Organization (WHO) Risk Groups/International Recommendations and Regulations In this ANPRM, RSPA is considering revising the classification criteria for infectious substances consistent with 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). In particular, RSPA is considering adopting risk groups and defining criteria developed by the World Health Organization (WHO) for Division 6.2 materials. These risk groups are described in the following table: [[Page 46845]] Risk Group Table ------------------------------------------------------------------------ Risk to Risk to the Risk Group Pathogen individuals community ------------------------------------------------------------------------ 4.......... Usually causes serious HIGH............ HIGH. human or animal disease and can be readily transmitted from one individual to another, directly or indirectly, and for which effective treatment and preventative measures are not usually available. 3.......... Usually causes serious HIGH............ LOW. human or animal disease but does not ordinarily spread from one infected individual to another and for which effective treatment and preventative measures are available. 2.......... Can cause human or MODERATE........ LOW. animal disease but is unlikely to be a serious hazard and, while capable of causing serious infection on exposure, effective treatment and preventive measures are available and only a limited risk of spreading infection exists. 1.......... Micro-organisms that NONE OR VERY LOW NONE OR VERY are unlikely to cause LOW. human or animal disease. ------------------------------------------------------------------------ Because the hazards posed by infectious substances vary greatly depending on the pathogenicity of the organism, mode and relative ease of transmission, and other factors, RSPA believes that classifying these materials based on the level of risk and applying requirements commensurate with the risk will ensure an adequate level of safety without imposing an undue burden on the regulated community. RSPA does not intend to provide a list of infectious substances that correlates with each risk group. Instead, RSPA would defer to the Department of Health and Human Services' Centers for Disease Control and Prevention (CDC), Office of Public Health, for guidance in determining the risk group of a specific material. RSPA seeks comments on whetheradoption of this risk-based classification criteria will improve safety in the transportation of infectious substances. B. Diagnostic Specimens Currently, in Sec. 173.134 of the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180), RSPA defers to the CDC regulations in 42 CFR Part 72 for packaging, hazard communication, and handling in the transportation of diagnostic specimens. Based upon reports of undisclosed and improperly prepared shipments of diagnostic specimens, RSPA believes that many shipments of diagnostic specimens are not properly identified and lack adequate hazard communication. RSPA also is concerned that, in some instances, packagings for diagnostic specimens lack sufficient integrity to survive normal handling in transportation. RSPA's Hazardous Materials Information System (HMIS) database contains a number of reports on packages of these materials that were damaged in transportation, causing costly delays and posing risks to cargo handlers, flight crews, emergency responders, and others who may have been exposed to infectious substances. At the same time, RSPA recognizes that thousands of shipments of diagnostic specimens are transported by highway without incident to and from clinics, households and laboratories by private or contract carriers. To ensure that diagnostic specimens are regulated consistent with the degree of risk posed by the material, RSPA is considering differentiating between a diagnostic specimen known or suspected to contain an infectious substance and a diagnostic specimen that is offered for transportation and transported for routine screening where there is a lower probability that a risk group 2 or 3 pathogen is present. RSPA is considering requirements that would treat diagnostic specimens that are known or suspected to contain a Risk Group 2, 3 or 4 pathogen as an infectious substance. For diagnostic specimens transported for routine screening (i.e., materials with a low probability of containing a Risk Group 2 or 3 pathogen), RSPA is considering whether to apply reduced packaging and hazard communication requirements. Proposed Sec. 173.196(c) specifies quantity limits for inner receptacles and for outer packagings, and requires that a packaging meet performance tests for non-bulk packagings in Subpart M of part 178 of the HMR except that the height for the drop test must be at least 1.2 meters (3.9 feet). C. Biological Products Under current provisions, biological products are excepted from the HMR provided they meet the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) regulations for the transfer of biological products specified in 9 CFR parts 102, 103, and 104 and 21 CFR parts 312 and 600-680. In this ANPRM, RSPA is considering whether to revise Sec. 173.134(b) to except only licensed biological products. A licensed biological product is defined in this ANPRM as a material approved by FDA for human use as a drug in the diagnosis, cure, mitigation, treatment, or prevention of disease and that is derived from biological sources, e.g., blood plasma and/or platelets and products obtained from these materials. In the case of biological products known to contain infectious substances, RSPA proposes that they be treated as infectious substances. RSPA is interested in receiving information on whether the risks associated with the transportation of licensed biological products warrant the granting of these exceptions and whether there are any risks that have been overlooked. RSPA is also interested in information concerning whether it is appropriate for RSPA to continue to defer to FDA and USDA regulations regarding these materials. In addition to the above, RSPA is considering whether to add a new special provision in Sec. 172.102 (consistent with ICAO Technical Instruction Special Provision A81) to except blood and blood products from existing quantity limits by aircraft when the materials are packaged in accordance with proposed Sec. 173.196, packaged in primary receptacles that do not exceed 500 ml (17 ounces), and contained in outer packagings not exceeding 4 L (1 gallon). D. Genetically Modified Organisms and Micro-organisms The UN Recommendations and the ICAO Technical Instructions treat any genetically modified material that meets the definition of Division 6.2 as an infectious substance. In addition, those international standards classify a genetically modified material that does not meet the definition of a Division 6.2 material, but is capable of altering animals, plants, or microbiological substances in a way not normally the result of natural reproduction, in hazard class 9 material. The UN Recommendations also contain a [[Page 46846]] provision that excludes from regulation genetically modified micro- organisms that are authorized and licensed for use by the government of the country of origin, transit, and destination. RSPA is considering whether to align the HMR with the international provisions for genetically modified organisms and micro-organisms. RSPA invites commenters to address whether RSPA should proceed with developing regulations for genetically modified micro-organisms or whether provisions for the safe transport of these substances are adequately addressed in other agencies' regulations. Are the conditions specified in proposed Sec. 173.140 that provide exceptions from the HMR for genetically modified micro-organisms and organisms justifiable in terms of safety and are they easily understood, or are there alternative safety controls that may be more appropriate? E. Hazard Communication RSPA is considering several options with respect to the marking or placarding of bulk packagings and transport vehicles containing infectious substances, including regulated medical waste (RMW), and is interested in receiving comments on those options. RSPA is considering requiring the display of an INFECTIOUS SUBSTANCE placard for any quantity of an infectious substance known or reasonably expected to contain a Risk Group 4 pathogen. RSPA seeks comment on whether a requirement to display placards on bulk packagings, freight containers, unit load devices, transport vehicles, or rail cars for shipments of infectious substances known or reasonably expected to contain a Risk Group 4 pathogen, regardless of the quantity of material, is necessary. RSPA is considering amending Sec. 172.504(e), Table 1, column 1, to include 6.2 infectious substances known or reasonably expected to contain a Risk Group 4 pathogen, and to add the appropriate references to an INFECTIOUS SUBSTANCE placard in columns 2 and 3 of the Table. Additionally, a new ``INFECTIOUS SUBSTANCE'' placard would be proposed, as shown below: BILLING CODE 4910-60-P [GRAPHIC] [TIFF OMITTED] TP02SE98.002 BILLING CODE 4910-60-C RSPA is also considering whether placards should be required to be displayed for bulk packagings, freight containers, unit load devices, transport vehicles or rail cars that contain other infectious substances, including RMW. If placarding is considered necessary, Table 2 of Sec. 172.504 would be revised to [[Page 46847]] require display of placards for these materials. Consistent with exceptions in Sec. 172.504(c), transport vehicles or freight containers that contain less than 454 kg (1,001 pounds) aggregate gross weight of infectious substances would not be required to be placarded. Alternatively, RSPA is considering a requirement to mark bulk packagings, freight containers, transport vehicles or rail cars with a display similar to that required for units that have been fumigated. For example, a rectangular display with the words ``REGULATED MEDICAL WASTE'' could be prominently displayed so that it can be readily seen by any person attempting to enter the interior of the bulk packaging, freight container, transport vehicle, or rail car. This marking is being considered for domestic transportation of infectious substances, other than those known or reasonably expected to contain a Risk Group 4 pathogen (see discussion above). RSPA requests comments on the following questions: 1. Should placarding be required for an infectious substance known or reasonably expected to contain a Risk Group 4 pathogen regardless of the quantity of material in the bulk packaging, freight container, transport vehicle or rail car? 2. For RMW, should placarding be required for a bulk packaging, freight container, transport vehicle or rail car which contains RMW? Alternatively, should an optional marking, such as ``REGULATED MEDICAL WASTE,'' be authorized in lieu of placards? 3. Should other infectious substances shipments (e.g., those known or reasonably expected to contain a Risk Group 2 or 3 pathogen) be required to display an INFECTIOUS SUBSTANCE placard? Should an optional marking, such as the term ``BIOHAZARD'' appearing in a rectangular display alongside the BIOHAZARD trefoil symbol, be authorized in lieu of placards? 4. Are placarding and marking proposals for infectious substances, as considered in this ANPRM, necessary and effective for communicating the infectious substance hazard to emergency responders? 5. Will transportation safety be significantly improved if placarding or identification number marking is required? 6. What costs would be incurred by shippers and carriers of infectious substances, including RMW, in fulfilling the proposed placarding requirements or the alternate marking requirements? Are there less costly alternatives to communicate the hazards of infectious substances, including RMW? 7. If placards are required, how many drivers would need to obtain a commercial drivers license (CDL) or a hazardous material (HM) endorsement to the CDL? What would be the associated impacts, including costs? 8. With respect to labels, RSPA is also considering revising the telephone number on its INFECTIOUS SUBSTANCE label to reflect the CDC's new toll free telephone number for reporting incidents involving infectious substances. Even though both CDC telephone numbers are currently in operation, should a transition period be provided to allow for use of existing inventories of currently required labels? If so, how long? F. Regulated Medical Waste RSPA is considering authorizing non-specification bulk packagings meeting conditions set forth in proposed Sec. 173.197(b) for RMW. Currently, bulk packagings are only authorized under the terms of 18 exemptions. This proposal would incorporate the provisions of some of these exemptions into the HMR to allow the use of non-specification bulk packagings for RMW under specific conditions, thereby eliminating the need for exemptions. These bulk packagings would require inner packagings that are securely closed and leak-resistant to be placed inside fiberglass or plastic containers, bins, or carts. With certain exceptions, these packagings have demonstrated through the exemption process that they provide an acceptable level of safety in transportation. RSPA is considering, also, whether to revise the quantity limitations in columns (9A) and (9B) of Sec. 172.101 for RMW to read ``No Limit'' to reflect the language in the ICAO Technical Instructions for maximum net quantity permitted per non-bulk package. RSPA notes that the ICAO Technical Instructions in Packing Instruction 622 restrict infectious substances, such as RMW, to non-bulk packagings only. Consistent with ICAO Technical Instructions, RSPA is considering whether to limit RMW in bulk packagings to non-air modes (railcar, motor vehicle, vessel) only. 1. Should the HMR be revised to authorize caster carts as reusable outer packagings for RMW packaged in plastic film bags, as currently authorized by 12 exemptions? If so, what specifications and size limitations are appropriate for caster carts? 2. Should the HMR be revised to authorize roll-off bins as reusable outer packagings for RMW packaged in plastic film bags, as currently authorized by 7 exemptions? If so, what specifications and size limitations are appropriate for roll-off bins? 3. If caster carts or roll-off bins are authorized for transporting RMW in plastic film bags, should film bags be required to be single or multiple ply with a total film thickness of 3 mils, a volume not more than 46 gallons, and a weight not more than 22 pounds, or are there more appropriate specifications? 4. If authorized for reuse to transport RMW, should roll-off bins and caster carts be decontaminated with a disinfectant solution after each use? 5. Should hospitals or clinics that use roll-off bins to transport RMW be required to register as shippers of bulk hazardous materials? 6. Should there be a time limit on the period a bin may hold RMW at the generator's site, to prevent the waste from decomposing and possibly releasing high concentrations of infectious vapors should a film bag be torn? 7. Should roll-off bins be allowed only if they are mechanically unloaded, without the inner packaging being handled manually? G. Materials of Trade Exception Under Docket HM-200, Hazardous Materials in Intrastate Commerce (62 FR 1216, as amended at 62 FR 49566 and 62 FR 51560), RSPA adopted exceptions from most of the requirements of the HMR for hazardous materials when transported as materials of trade. Materials of trade include certain hazardous materials carried by a private motor carrier engaged in a principal business other than transportation, such as lawn care, plumbing, welding, door-to-door sale of consumer goods, and farm operations. Specific limitations (such as maximum gross weight of materials of trade that may be carried on a motor vehicle) and safety provisions (such as packaging and hazard communication) contained in current Sec. 173.6 achieve an acceptable level of safety at a minimal cost to the carrier. In this ANPRM, RSPA is inviting comments on whether to amend Sec. 173.6 to permit certain biological products, diagnostic specimens and RMW in Division 6.2, to be transported by private carraige as materials of trade. Entities, such as home health care and diagnostic laboratories, that transport smaller amounts of infectious substances in direct support of a principal business other than transportation would be included. RSPA requests comments on whether an acceptable level of safety would be [[Page 46848]] achieved, also, through a materials of trade exception for infectious substances. What, if any, hazard communication should be required for carriage of such materials? If so, what should the communication be? Section 173.6 specifies quantity limits for the packaging and the motor vehicle, and minimal hazard communication, for materials transported by a private motor carrier engaged in a principal business other than the transportation of hazardous materials. RSPA invites comments on the costs and benefits associated with this proposal and whether special recognition should be given to private carriage by highway, including the transportation of risk group 4 pathogens. H. Discussion of Petition for Rulemaking On August 28, 1997, The Medical Waste Institute (MWI) submitted a petition for rulemaking (P-1350) requesting relief for the transportation of waste cultures and stocks that meet the definition for infectious substances. This petition and its enclosures have been entered as part of the public docket for this rulemaking and can be obtained by contacting the Department of Transportation Dockets Management System using the information provided in the address section at the beginning of this rule. Specifically, MWI requested that RSPA revise the HMR to allow contract and private motor carriers to transport discarded cultures and stocks of infectious substances in non-specification packagings if the carriers use dedicated vehicles. The petitioners requested that this relief be authorized for Biosafety Level 1, 2, and 3 materials, as defined in Health and Human Services publication No. 93-8395. These biosafety levels are based on the same WHO risk groups as referenced in Sec. 173.134(a) of the accompanying regulatory text. Currently, the HMR allows this type of transportation for RMW that does not contain a waste culture or stock of an infectious substance. The HMR require a waste culture or stock to be transported in a packaging meeting the performance criteria in Sec. 178.609. Section 178.609 specifies requirements for a triple packaging that survives several rigorous performance tests, including a 9 m (30-foot) drop test and a 1 m (3- foot) puncture test. By comparison, Sec. 173.197 currently requires that the packaging for RMW that does not contain a waste culture or stock of an infectious substance meet performance criteria of a UN specification packaging at the Packing Group II performance level contained in 49 CFR Part 178, Subpart M, except Sec. 178.609. In addition, when packaging authorized in Sec. 173.134 is used, RSPA currently requires that the material be transported in a dedicated vehicle by a private or contract carrier and conform to Biosafety Levels 1, 2, or 3. MWI included with its petition for rulemaking DOT and State incident data on infectious substances from 1989 through March 1997. The petitioner stated that the information shows a relatively low number of hazardous materials incidents in the U.S. involving a release of RMW transported by highway. MWI further said that: The CDC reports hospital waste disposal practices have not resulted in epidemiologic evidence of disease in communities; Emergency responders take the same precautions with infectious substance releases as they do with RMW releases; Packing group II packagings are not justified for discarded cultures and stocks; Discarded cultures and stocks from non-health care settings pose the same level of risk as those from health care settings; and The HMR's general packaging requirements coupled with OSHA's bloodborne packaging standards have a proven safety record. From these points, the MWI concluded that the current packagings required in the HMR for discarded cultures and stocks are not justified because they are onerous and expensive and lack a safety record that proves their actual public health and safety benefit. The MWI also enclosed an EPA press release announcing its medical waste incinerator program, and language that MWI suggests justifies discarded cultures and stocks to be defined as RMW when transported by private or contract motor carriers. As a result of a provision in Sec. 171.15(b) and the wording of the INFECTIOUS SUBSTANCE label in Sec. 172.432, many releases of infectious substances are reported directly to CDC but not to RSPA. Section 171.15(b) allows carriers that report infectious substance (etiologic agent) incidents the option of reporting the event to the CDC or DOT. Although Sec. 171.15(c) requires incident information reported to CDC to be reported to RSPA in the form of a written report, often this information is not provided to RSPA. This has resulted in an under- reporting of these events in RSPA's HMIS incident database. Further, pre-1996 HMR exceptions for packagings containing 50 ml (1.7 ounces) or less of an infectious substance (known then as an etiologic agent) were often misapplied and used to ship larger amounts of an infectious substance. The Sec. 171.15(b) exception, when properly applied, relieved carriers from immediate telephonic notification requirements of the HMR. It was intended to avoid duplication with CDC regulations because these materials were subject to CDC requirements in 42 CFR Part 72. Because a number of incidents involving infectious substances were not reported to DOT, RSPA is considering revising Sec. 171.15 to clarify that any incident involving the release of an infectious substance be reported to RSPA, in addition to the CDC, in the form of an incident report. Over the last few years, individuals and companies commenting on infectious substance rulemakings, or on their own initiative, reported to RSPA information concerning infectious substance releases. They have reported witnessing blood pouring from rolloffs and freight containers transporting RMW, the disposal of AIDS-contaminated blood in municipal waste cans, overturned vehicles that have released diagnostic specimens on the highways, leaking non-bulk packagings of RMW, ruptured packages containing diagnostic specimens being transported by aircraft, releases of treatment-resistant diseases from insufficient packaging, and used sharps that punctured inner packagings. As a result of information received from these sources, and through RSPA's own initiative and incident reporting system, RSPA is now considering whether to take a more conservative approach, on the side of safety, to the transportation of waste cultures and stocks. Several commenters, responding to earlier NPRMs issued on this subject under Docket HM-181G, stated that a high concentration of micro-organisms exist in cultures and stocks of infectious substances. These micro-organisms have the potential to cause disease and, therefore, require special handling. CDC supported special handling of these materials in a October 24, 1996 final rule (61 FR 55190) and in response to RSPA's rulemaking actions on infectious substances issued under Docket HM-181G. In meetings and conversations with RSPA, CDC recommended more rigorous packagings for cultures and stocks of infectious substances. Therefore, RSPA did not base its current regulations for these materials solely on incident reports. In addition, RSPA recommends, through guidance provided in the 1996 North American Emergency Response Guidebook, that emergency responders treat infectious substances and RMW [[Page 46849]] the same since both are Division 6.2 materials. RSPA finds, through experience gained under exemption DOT-E 11588, that Packing Group II packagings transported by a private or contract carrier in a dedicated vehicle provide an acceptable level of protection for waste cultures and stocks of infectious substances. Private and contract carriers that transport these materials have an increased level of knowledge from working with these materials. Moreover, use of dedicated vehicles limits exposure of these packagings to other packagings and assures that shipments are handled by experienced personnel. RSPA also finds that the general packaging requirements in Secs. 173.24 and 173.24a coupled with OSHA's packaging requirements for bloodborne pathogens contained in 29 CFR 1910.1030 are adequate for less virulent infectious substances. RSPA seeks specific comments on the MWI petition for rulemaking. I. Segregation from Foodstuffs RSPA currently requires segregation of poisons from foodstuffs. Is there sufficient justification to support imposing similar restrictions on all or certain packages containing infectious substances? III. Section-by-Section Review This discussion is included to provide the reader with additional information to more fully explain potential approaches. RSPA seeks comments on these potential approaches and may publish an NPRM to further refine these approaches or to propose alternatives to these approaches based on comments we receive. Section 171.14 Paragraph (f) would be added to establish a two-year transition period for the use of infectious substance labels that do not include the CDC's new toll-free telephone number for reporting infectious substance incidents. Section 171.15 In paragraphs (a) (3) and (b), the term ``etiologic agents'' would be revised to read ``infectious substances.'' In paragraph (b), information would be added to clarify that a written report, DOT Form F 5800.1, is required for all infectious substance incidents, including those reported to the CDC. Section 172.101 For the entry, ``Regulated medical waste'', the letter ``D'' in column (1) would be removed, in column (7) the reference to Special Provision A14 would be removed, and columns (9A) and (9B) would be amended to indicate ``No limit'' as opposed to ``Forbidden'' for quantity limitations. These changes would harmonize requirements in the HMR with those in the ICAO Technical Instructions and facilitate the transport of RMW in non-bulk packagings by aircraft. It should be noted that, although ``No limit'' would be specified for per-package quantity limits in the Hazardous Materials Table (the Table), Special Provision A13 would be revised to prohibit the use of bulk packagings aboard aircraft. Further, quantity limits may apply with regard to the types of packagings authorized for RMW in Part 173 and to air transportation under Sec. 175.75. RSPA requests comments concerning the need, if any, for further limitations or relaxations on the quantities of RMW authorized for transportation by aircraft. For the entries ``Infectious substances, affecting animals only'' and ``Infectious substances, affecting humans'' new special provisions would be added in Column (7). One, A81, would provide relief from quantity limits for the transport of blood or blood products known to contain or suspected of containing infectious substances when in primary receptacles not exceeding 500 ml (17 ounces) and in outer packagings not exceeding 4 L (1 gallon) and packaged in accordance with Sec. 173.196. The second, A82, would provide relief from UN standard packaging for transporting body parts, whole organs, and whole bodies. A new entry, ``Genetically modified micro-organisms'' would be added to the Table as a Class 9 (miscellaneous) material consistent with the entry in the UN Recommendations, the ICAO Technical Instructions and the IMDG Code. Another new entry, ``Diagnostic Specimen'', would be added to the Table as a Division 6.2 material. However, this proper shipping name would be authorized only for diagnostic specimens excepted under proposed Sec. 173.196(c). There would be no identification number, hazard warning label, or packing group assignment. In order to eliminate any confusion and costs that could result from the use of several proper shipping names for the same material, the other proper shipping names for infectious waste that are authorized in the UN Recommendation and the ICAO Technical Instructions, ``Biomedical waste, n.o.s.'', ``Clinical waste, unspecified, n.o.s.'', and ``Medical waste, n.o.s.'', would not be added to Sec. 172.101. RSPA believes the proper shipping name ``Regulated medical waste'' more accurately describes the material and is the preferable shipping name. Also, it is RSPA's understanding that the other names were added to satisfy requests from specific countries that were already using these shipping names. International shipments using these names would be authorized for transport to their final destinations under the import-export provisions in Secs. 171.11, 171.12, and 171.12a. Section 172.102 Special Provision A13 would be revised to prohibit the use of bulk packagings for RMW aboard aircraft, thus imposing a maximum gross mass of 400 kg or 450 L per package. Special Provision A14 would be removed. Two new Special Provisions, A81 and A82, that are consistent with A81 in the ICAO Technical Instructions, would be added, as discussed earlier in this section-by-section review under Sec. 172.101. Section 172.432 The current telephone number, ``404-633-5313'', printed on the INFECTIOUS SUBSTANCE label for reporting infectious substance incidents would be changed at the request of CDC to reflect its new toll free phone number for this purpose, to ``800-232-0124''. A two-year transition period would be provided in Sec. 171.14 to allow shippers to exhaust their label inventories. Section 173.6 Paragraph (a)(4) would be redesignated as paragraph (a)(5) and a new paragraph (a)(4) would be added to permit certain biological products, diagnostic specimens and RMW in Division 6.2 to be transported by entities, such as home health care providers and diagnostic laboratories, that transport smaller amounts of infectious substances in direct support of a principal business other than the transportation of hazardous materials. Section 173.134 The criteria for Division 6.2 materials specified in Sec. 173.134 would be revised based on the UN Recommendations and the 1999-2000 edition of the ICAO Technical Instructions. This section would also be revised to incorporate certain domestic exceptions for transportation by highway. The current definition for infectious substances would be revised to remove the term ``viable microorganism'' and clarify the term ``pathogens.'' The defining criteria would exclude toxins, include the WHO risk groups, and except from Division 6.2 infectious substances that are unlikely to cause disease, i.e., risk group [[Page 46850]] 1 pathogens. The definitions for the terms ``diagnostic specimen'' and ``biological product'' would be amended to include the WHO risk groups and be compatible with the ICAO Technical Instructions. Paragraph (b) would be amended to except licensed biological products from regulation under the HMR and, under certain conditions, except diagnostic specimens and biological products where a low probability exists that they contain a WHO risk group 2 or 3 pathogen. RSPA is considering requiring that animals which contain or are contaminated with genetically modified micro-organisms or organisms (Sec. 173.140(d)(4)) that meet the criteria of an infectious substance (Sec. 173.134(c)(5)) be transported under terms and conditions approved by RSPA's Associate Administrator for Hazardous Materials Safety, consistent with standards specified in the UN Recommendations and ICAO Technical Instructions. Section 173.140 New paragraphs (c) and (d) would be added to provide defining criteria and exceptions for a genetically modified micro-organism that does not meet the definition of a Division 6.2 material but has the potential to alter animals, plants, or the environment. These materials would be assigned to the Class 9 hazard class. A genetically modified micro-organism that meets the criteria for a Division 6.2 material would be classed and described as an infectious substance. A genetically modified micro-organism would be required to be packaged in accordance with Sec. 173.196, except that the packagings need not be marked in accordance with Sec. 178.503 or tested in accordance with Sec. 178.609. In addition, the quantity in the primary receptacles would be limited to a maximum of 100 ml (3.4 ounces) or 100 g (4 ounces) for consistency with the ICAO Technical Instructions. A Class 9 genetically modified micro-organism and organism packages would not be assigned a packing group and would be excepted from all requirements in the HMR if authorized for final distribution and use by a U.S. Government agency. Section 173.196 Existing paragraph (a) would be revised and redesignated as paragraph (b). New paragraph (a) would clarify that Sec. 173.196 prescribes non-bulk packagings for infectious substances. Existing paragraphs (b), (c), (d), and (e) would be incorporated in new paragraph (b). New paragraph (b) would include an exception from requirements for an absorbent material for solid infectious substances, and other revisions to provide consistency with the ICAO Technical Instructions. These revisions would include package and overpack marking requirements and requirements to ensure the containment integrity of the packagings during air transport, including circumstances whe","truncated":true,"body_characters":89361}