{"operation":"document","citation":"66 FR 6942","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":"2001-01-22","effective_on":null,"summary":"RSPA is proposing to revise transportation requirements for infectious substances, including regulated medical waste, by adopting defining criteria and packaging requirements for infectious substances and genetically modified micro-organisms that are consistent with international standards; revising the current broad exceptions for diagnostic specimens and biological products; and authorizing bulk packaging options for regulated medical waste consistent with requirements in international standards and DOT exemptions. These proposals are intended to assure an acceptable level of safety for the transportation of infectious substances and to facilitate domestic and international transportation.","machine_formats":{"json":"https://regulus.evalyn.ai/document/federal-register-01-92.json","markdown":"https://regulus.evalyn.ai/document/federal-register-01-92.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-01-92","source_url":"https://www.federalregister.gov/documents/2001/01/22/01-92/hazardous-materials-revision-to-standards-for-infectious-substances-and-genetically-modified","body":"Federal Register, Volume 66 Issue 14 (Monday, January 22, 2001) [Federal Register Volume 66, Number 14 (Monday, January 22, 2001)] [Proposed Rules] [Pages 6942-6962] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 01-92] [[Page 6941]] ----------------------------------------------------------------------- Part VI Department of Transportation ----------------------------------------------------------------------- Research and Special Programs Administration ----------------------------------------------------------------------- 49 CFR Parts 171, 172, 173, 177 and 178 Hazardous Materials: Revision to Standards for Infectious Substances and Genetically Modified Micro-Organisms; Proposed Rule Federal Register / Vol. 66 , No. 14 / Monday, January 22, 2001 / Proposed Rules [[Page 6942]] ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Research and Special Programs Administration 49 CFR Parts 171, 172, 173, 177, and 178 [Docket No. RSPA-98-3971 (HM-226)] RIN 2137-AD13 Hazardous Materials: Revision to Standards for Infectious Substances and Genetically Modified Micro-Organisms AGENCY: Research and Special Programs Administration (RSPA), DOT. ACTION: Notice of proposed rulemaking. ----------------------------------------------------------------------- SUMMARY: RSPA is proposing to revise transportation requirements for infectious substances, including regulated medical waste, by adopting defining criteria and packaging requirements for infectious substances and genetically modified micro-organisms that are consistent with international standards; revising the current broad exceptions for diagnostic specimens and biological products; and authorizing bulk packaging options for regulated medical waste consistent with requirements in international standards and DOT exemptions. These proposals are intended to assure an acceptable level of safety for the transportation of infectious substances and to facilitate domestic and international transportation. DATES: Comments. Submit comments by April 23, 2001. To the extent possible, we will consider comments received after this date in making our decision on a final rule. ADDRESSES: Submit 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 Docket Number RSPA- 98-3971 (HM-226) and be submitted in two copies. If you wish to receive confirmation of receipt of your written comments, include a self- addressed, stamped postcard. You may also submit comments by e-mail by accessing the Dockets Management System web site at ``http:// dms.dot.gov/'' and following the instructions for submitting a document electronically. The Dockets Management System is located on the Plaza level of the Nassif Building at the Department of Transportation at the above address. You can review public dockets there between the hours of 9 a.m. and 5 p.m., Monday through Friday, except federal holidays. You can also review comments on-line at the DOT Dockets Management System web site at ``http://dms.dot.gov/.'' FOR FURTHER INFORMATION CONTACT: Eileen Edmonson or Susan Gorsky (202) 366-8553, Office of Hazardous Materials Standards, Research and Special Programs Administration. SUPPLEMENTARY INFORMATION: List of Topics I. Background II. Need for New Regulations III. Summary of Proposals in NPRM A. Classification Criteria for Infectious Substances B. Packaging Requirements for Infectious Substances C. Exceptions for Domestic Shipments of Infectious Substances D. Diagnostic Specimens E. Biological Products F. Genetically Modified Micro-Organisms G. Regulated Medical Waste H. Used Health Care Products I. Hazard Communication J. Petition for Rulemaking IV. Section-by-Section Review V. Regulations of Other Agencies A. Centers for Disease Control and Prevention B. Occupational Safety and Health Administration C. Food and Drug Administration D. U.S. Department of Agriculture E. Actions to Assure Regulatory Consistency VI. Regulatory Analyses and Notices A. Executive Order 12866 and DOT Regulatory Policies and Procedures B. Executive Order 13132 C. Executive Order 13084 D. Regulatory Flexibility Act E. Paperwork Reduction Act F. Regulation Identifier Number (RIN) G. Unfunded Mandates Reform Act H. Environmental Assessment I. Background On September 2, 1998, the Research and Special Programs Administration (RSPA, we) published an advance notice of proposed rulemaking (ANPRM) on revisions to the current requirements in the Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) applicable to the transportation of infectious substances, Division 6.2, including regulated medical waste (63 FR 46844). We asked a variety of questions concerning classification criteria, hazard communication, and packaging requirements for infectious substances consistent with international standards; revisions to the current exceptions in the HMR for diagnostic specimens and biological products; and additional packaging requirements for regulated medical waste (RMW). In addition, we conducted an electronic public meeting on the Internet from September 14-16, 1998, to facilitate public comment on the issues discussed in the ANPRM. For the Internet meeting, we posted the questions listed in the ANPRM and additional questions to encourage commenters to provide specific quantitative information relative to the transportation of infectious substances. We received 89 comments in response to the ANPRM and the Internet meeting. Several commenters submitted more than one response. Most comments came from industry associations, colleges and universities, laboratories, and medical waste transporters. Comments were also submitted by state veterinary laboratories, state departments of agriculture, health insurance companies, a blood supplier, equipment suppliers, private citizens, a fire department, a union, and the U.S. Department of Agriculture. II. Need for New Regulations Many commenters question the need for increased regulation of infectious substances. They cite their experience with transporting these materials to support their view that there is little or no safety risk associated with such transportation and, thus, no justification for the changes proposed in the ANPRM. Commenters further assert that the proposed packaging and hazard communication requirements will impose significant transportation costs that are not justified by the safety risks involved with shipping infectious substances. We do not agree that there is little risk associated with the transportation of infectious substances. RSPA's Hazardous Materials Information System (HMIS) includes reports of carriers discovering leaking, unlabeled packages containing blood and other potentially infectious material and of packages containing infectious materials being damaged in handling and releasing their contents. The Centers for Disease Control receives about 400 reports each year from carriers who detect leakage or other damage to packages of infectious substances. Releases of infectious substances in transportation present the possibility of exposure for transportation workers and the general public and can result in costly shipping delays and clean-up efforts. Further, as a result of a provision in the accident reporting requirements in the HMR and the wording of the INFECTIOUS SUBSTANCE label, many releases of infectious substances are reported to CDC rather than to RSPA. Although the HMR require incident information reported to CDC also to be [[Page 6943]] reported to RSPA in a written incident report, carriers do not routinely do so. This has resulted in under-reporting of these incidents in RSPA's HMIS data base. Over the last several years, individuals and companies commenting on infectious substances rulemakings or on their own initiative have reported information concerning infectious substance releases. These reports include blood pouring from roll-offs and freight containers transporting regulated medical waste (RMW), the disposal of HIV- contaminated blood in municipal waste cans, overturned vehicles that have released diagnostic specimens on highways, ruptured packages containing diagnostic specimens being transported by aircraft, releases of treatment-resistant diseases from inadequate packaging, and used sharps that puncture inner packagings. Because of these reports and our own findings, we believe that the current regulatory requirements applicable to transportation of Division 6.2 materials should be strengthened. Accordingly, in this NPRM, we are proposing the following changes to the HMR: Adoption of new classification criteria for infectious substances based on defining criteria developed by the World Health Organization and consistent with standards contained in the United Nations Recommendations on the Transport of Dangerous Goods and the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air. Revision of current packaging requirements for Division 6.2 materials for consistency with international performance standards. Elimination of the current exception from requirements in the HMR for diagnostic specimens to impose certain packaging and hazard communication requirements. Diagnostic specimens transported in dedicated motor vehicles by private or contract carriers would continue to be excepted from most requirements in the HMR. Modification of the current exception from requirements in the HMR for biological products, limiting the exception to biological products licensed for use under current regulations of the Food and Drug Administration or U.S. Department of Agriculture. New transportation requirements for the transportation of genetically modified micro-organisms consistent with international requirements. New bulk packaging options for the transportation of RMW, based on current exemption provisions. New hazard communication requirements for shipments of Division 6.2 materials. III. Summary of Proposals in NPRM A. Classification Criteria for Infectious Substances In the ANPRM, we indicated that we are 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, we said we are considering adopting the risk groups and defining criteria developed by the World Health Organization (WHO) for Division 6.2 materials. Commenters who support international harmonization of the classification criteria for infectious substances note that the proposal in the ANPRM would facilitate shipment of infectious substances in international commerce and by aircraft. Commenters opposed to the proposal are concerned about the possible misinterpretation and misapplication of the WHO risk group criteria. These commenters believe that the WHO risk group definitions are poorly worded and subject to broad interpretation and, as a result, assigning materials to risk group categories may be difficult or impossible. As we stated in the ANPRM, the hazards posed by Division 6.2 materials vary greatly depending on the pathogenicity of the organism, the mode and relative ease of transmission, and other factors (63 FR 46845). It should be noted that determining if a material is infectious has always included subjective analysis in the absence of actual testing. Classifying these materials based on the level of risk and applying transportation requirements commensurate with that risk should ensure an adequate level of safety without imposing an undue burden on the regulated community. International harmonization of transportation standards also facilitates foreign trade and helps U.S. companies compete in the global economy. Most passenger and cargo air carriers currently require shipments of Division 6.2 materials to conform to the international standards. Thus, in this NPRM, we are proposing to define Division 6.2 materials using the WHO risk group criteria. The proposal would 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 to a risk group would be based on the known medical history of the patient or animal, endemic local conditions, symptoms of the patient or animal, or professional judgement concerning the individual circumstances of the patient or animal. Division 6.2 materials assigned to Risk Group 1 would be excepted from requirements in the HMR. Commenters to the ANPRM are concerned that updated lists indicating risk group assignments for specific pathogens are difficult to obtain. We are aware of several organizations that maintain such lists. The American Biological Safety Association (ABSA) lists bacteria, fungi, viruses, and parasites according to their assigned risk groups. These lists can be found on-line at the ABSA web site ( http://www.absa.org/ ). In addition, the ABSA web site includes links to risk group listings from Canada (in Health Canada's Laboratory Biosafety Guidelines at http://www.hc-sc.gc.ca/hpb/lcdc/biosafty/docs/index.html ) and to Belguim's Biosafety Server ( http://biosafety.ihe.be/ ), which includes information on European regulation of infectious substances. The ABSA web site also includes information on the regulation of infectious substances in Australia, Brazil, Japan, and New Zealand at http://biosafety.ihe.be/Menu/BiosWorld.html . We plan to work with WHO and CDC to assure that updated guidance for determining the risk groups for specific materials is easily available. B. Packaging Requirements for Infectious Substances The HMR currently require an infectious substance to be packaged in a triple packaging that includes a water-tight primary receptacle, a water-tight secondary packaging, and an outer packaging. The primary receptacle or secondary packaging must be capable of withstanding, without leakage, an internal pressure that produces a pressure differential of not less than 95kPa (0.95 bar, 14 psi) and temperatures in the range of -40 deg.C to +55 deg.C (-40 deg.F to +131 deg.F). The triple packaging must be capable of passing the performance tests specified in Sec. 178.609. In this NPRM, we propose to incorporate several changes to the packaging requirements and performance tests to make them [[Page 6944]] consistent with the UN Recommendations and ICAO Technical Instructions. For example, we propose to require manufacturers to mark packagings represented as conforming to the specifications for infectious substances packagings in the HMR consistent with UN marking requirements. In addition, we propose to require manufacturers to retain packaging design qualification records and to retest packagings every 24 months. Further, we propose to replace the current requirement for a water immersion test with a water-spray test that simulates exposure to rainfall, as required by the ICAO Technical Instructions. Similarly, we propose to incorporate the selective testing provisions in the UN Recommendations and ICAO Technical Instructions to allow variations in the primary receptacles within the secondary packaging without further testing of the completed package if an equivalent level of performance is maintained. C. Exceptions for Domestic Shipments of Infectious Substances In the September 1998 ANPRM, we noted that we are considering several exceptions from HMR requirements for domestic shipments of infectious substances by motor carrier. For example, the HMR include exceptions from most requirements of the HMR for hazardous materials transported as materials of trade. Materials of trade include hazardous materials carried by private motor carriers engaged in a principal business other than transportation, such as lawn care, plumbing, welding, and door-to-door sale of consumer goods. The materials of trade exception limits the maximum gross weight of materials of trade that may be carried on a motor vehicle and includes minimum packaging and hazard communication requirements. In the ANPRM, we invited comments on expanding the materials of trade exception to permit certain biological products, diagnostic specimens, and RMW to be transported by private carriage as materials of trade. Commenters opposed to a materials of trade exception for infectious substances assert that such an exception would not provide an adequate level of safety for transporting infectious materials. Commenters who support a materials of trade exception note that it would reduce potential transportation costs, particularly if we remove the current exceptions in the HMR for diagnostic specimens and biological products. In this NPRM, we are proposing to expand the materials of trade exceptions currently permitted under Sec. 173.6 of the HMR to include certain biological products, diagnostic specimens, and RMW, including cultures and stocks. As proposed, this exception does not apply to materials known to contain or suspected of containing infectious substances in Risk Group 4. The proposed exception specifies that the material must be contained in combination packagings consisting of one or more inner packagings inside an outer packaging. The capacity of each inner packaging may not exceed 0.5 kg (1.1 pound) or 0.5 L (17 ounces), and the capacity of the outer packaging may not exceed 4 kg (8.8 pounds) or 4 L (1 gallon). The proposed exception also permits combination packagings consisting of a single inner packaging with a capacity that does not exceed 16 kg (35.2 pounds) or 16 L (4.2 gallons) contained inside a single outer packaging. For RMW in combination packagings, each inner packaging may not exceed 4 kg (8.8 pounds) or 4 L (1 gallon) and the outer packaging may not exceed 16 kg (35.2 pounds) or 16 L (4.2 gallons). Under this proposal, infectious substances transported as materials of trade are subject to the general packaging, hazard communication, and motor vehicle operator notification requirements currently specified in Sec. 173.6. The proposed materials of trade exception would apply to entities such as home health care providers and diagnostic laboratories that transport smaller amounts of infectious substances. We believe that the increased knowledge of the personnel handling these materials, most of whom are trained in the requirements of the Occupational Safety and Health Administration's (OSHA) Universal Precaution regulations for handling potentially contaminated material, will substantially reduce the risks associated with their transportation. In addition, the exception imposes minimum packaging requirements, at minimal cost, for materials currently excepted from the HMR. D. Diagnostic Specimens In the ANPRM, we proposed removing the existing broad exception from the HMR for diagnostic specimens and creating a regulatory system based on the WHO risk group definitions that requires diagnostic specimens to be packaged, described, and transported in a manner consistent with their level of risk. We proposed retaining the broad exception from the HMR for diagnostic specimens assigned to Risk Group 1 only. Further, we proposed exceptions to distinguish between a diagnostic specimen known or suspected to contain an infectious substance and one sent for routine testing. The majority of comments we received in response to the ANPRM address the proposed regulations for diagnostic specimens. Most commenters oppose increased regulation for diagnostic specimens, suggesting that the proposed regulations are not justified by the safety record and will be difficult and costly to implement. Commenters further state that the proposed regulations could result in shipment delays, making early detection and treatment of disease difficult. Commenters note that shippers of diagnostic specimens may have little or no knowledge of what pathogens a given specimen may contain, making application of the WHO risk groups to such materials difficult, at best. Finally, commenters state that the proposed regulations could significantly increase health care costs. Commenters who support regulation of diagnostic specimens note that releases of these materials do occur in transportation. These commenters generally support removal of the current exception from the HMR for diagnostic specimens to ensure packaging quality and to protect transportation workers and the general public from the risk of exposure to potentially infectious materials. We agree with commenters that diagnostic specimens should be subject to regulation under the HMR. Our HMIS data base includes reports of packages containing these materials that were damaged in transportation, resulting in delays and possible risk to cargo handlers, flight crews, emergency responders, and the general public. However, we also agree with commenters that the regulatory requirements proposed in the ANRPM could increase transportation costs for shipment of these materials. Accordingly, in this NPRM, we are proposing regulations applicable to the transportation of diagnostic specimens that are consistent with proposed amendments to the UN Recommendations. We propose a new entry in the Hazardous Materials Table--``Diagnostic Specimen.'' There is no UN number, hazard warning label, or packing group assignment. Under this proposal, diagnostic specimens meeting the definition of a Risk Group 4 material are classed and transported as Division 6.2 materials, UN 2814 or UN 2900. All other diagnostic specimens must be packaged in primary receptacles packed inside secondary packaging to preclude breakage, punctures, or leakage, and, for liquids, with sufficient absorbent [[Page 6945]] material to absorb the entire contents of the primary receptacle. The secondary packaging must be secured in outer packagings with suitable cushioning material. For liquids transported by aircraft, either the primary receptacle or the secondary packaging must be capable of withstanding an internal pressure producing a pressure differential of at least 95kPa (0.95 bar, 14 psi). The completed package must be capable of passing a drop test from a height of at least 1.2 meters (3.9 feet). The package must be marked with the words ``Diagnostic Specimens.'' Diagnostic specimens shipped in conformance with these proposed provisions are excepted from other requirements in the HMR, except that diagnostic specimens transported on board aircraft are subject to the incident reporting requirements in Secs. 171.15 and 171.16. Under this proposal, offerors and transporters of diagnostic specimens must be informed of the diagnostic specimen packaging requirements. In addition to the materials of trade exception discussed above, we are also proposing a complete exception from the HMR for diagnostic specimens transported by private or contract motor carriers. Based on comments received in response to the ANPRM, it is our understanding that most diagnostic specimens are shipped from collection sites (e.g., physicians' offices, nursing homes, clinics, etc.) to testing laboratories by private or contract couriers in dedicated vehicles. The couriers are familiar with the materials they transport and trained in the application of the OSHA Universal Precautions for handling materials that may contain infectious substances. Our proposal would require couriers to be informed about the materials they are transporting. This proposed exception will enable the transportation of diagnostic specimens quickly, efficiently, and safely to testing laboratories. It should be noted that waste diagnostic specimens--that is, diagnostic specimens that meet the proposed definition for RMW in this NPRM--could not be transported under the exceptions proposed in this NPRM for the transportation of diagnostic specimens. Waste diagnostic specimens would lose their identity as diagnostic specimens for purposes of the HMR and would have to be transported in accordance with the HMR requirements applicable to RMW. Taken together, we believe that these proposals for the transportation of diagnostic specimens are cost-effective, practical, and easy to understand and implement. Most important, these proposals will assure an adequate level of safety. E. Biological Products Commenters to the ANPRM generally support its proposals concerning transportation of biological products. Under current provisions, biological products are excepted from the HMR provided they meet Food and Drug Administration (FDA) or U.S. Department of Agriculture (USDA) regulations governing the transfer of biological products. In this NPRM, we propose to limit this exception to biological products that meet the definition of a Risk Group 1 material or are licensed for use under current FDA or USDA regulations. We propose to require unlicensed biological products meeting the definition of a Risk Group 2, 3, or 4 infectious substance to be classed as infectious substances, Division 6.2, and packaged in specification packagings authorized for the transportation of infectious substances. In addition, we are proposing to add a special provision in Sec. 172.102, consistent with ICAO Technical Instruction Special Provision A81, to except blood and blood products from current quantity limits for shipments by air when the materials are packaged in primary receptacles that do not exceed 500 ml (17 ounces) and contained in outer packagings not exceeding 4 L (1 gallon). We also propose to except from all HMR requirements blood collected for blood transfusions, blood collected for the preparation of blood products, blood products intended for transplant, and tissues and organs intended for transplant. It should be noted that waste biological products--that is, biological products that meet the proposed definition for RMW in this NPRM--may not be transported under the exceptions proposed in this NPRM for the transportation of biological products. Waste biological products lose their identity as biological products for purposes of the HMR and, if they contain infectious substances, must be transported in accordance with the HMR requirements applicable to RMW. F. Genetically Modified Micro-Organisms The UN Recommendations and the ICAO Technical Instructions treat any genetically modified micro-organism that meets the definition of a Division 6.2 material as an infectious substance. In addition, these international standards class a genetically modified micro-organism that does not meet the definition of a Division 6.2 material, but is capable of altering plants, animals, or microbiological substances in a way not normally the result of natural reproduction, as a Class 9 material. The UN Recommendations also contain a provision that excludes from regulation genetically modified micro-organisms that are authorized and licensed for use by the government of origin, transit, and destination. In the ANPRM, we invited comment on whether the HMR should incorporate the international transportation standards for genetically modified micro-organisms. Commenters who addressed this issue are concerned that the proposed regulations could interfere with food and animal production. We appreciate their concerns, but we believe that the potential for environmental and property damage as a result of the release of genetically modified micro-organisms in transportation justifies their regulation as Class 9 materials. Accordingly, in this NPRM, we propose to add ``Genetically modified micro-organism'' to the Hazardous Materials Table as a Class 9 material. Under this proposal, these materials must be packaged in conformance with the requirements for packaging infectious substances, except that the packagings need not be marked or tested in accordance with Part 178 requirements. The NPRM proposes two exceptions applicable to the transportation of genetically modified micro-organisms. First, we propose to except genetically modified micro-organisms from all requirements in the HMR if a federal government agency authorizes their final distribution and use. Second, we propose to except genetically modified micro-organisms from HMR requirements when transported in a non-passenger-carrying transport vehicle operated by a private or contract motor carrier. The materials must be packaged to conform to the provisions described above, and the package must be marked with the proper shipping name ``Genetically modified micro-organism.'' Further, our proposal requires couriers to be informed about the materials they are transporting. G. Regulated Medical Waste Commenters generally support the proposals outlined in the ANPRM to permit transportation of RMW in non-specification bulk packagings. Currently, bulk packagings for the transportation of RMW are only authorized under the terms of 29 exemptions. For the most part, these [[Page 6946]] packagings have demonstrated that they provide an acceptable level of safety in transportation. To ensure consistency with international regulations and to provide the broadest selection of authorized bulk packagings, we are also proposing to allow the use of ``Large Packagings,'' which are intermediate bulk packagings containing one or more inner packagings consistent with the requirements of the UN Recommendations. A definition for these packagings was proposed in an NPRM issued under Docket HM-215D, published October 23, 2000 (65 FR 63294) and in the International Maritime Dangerous Goods Code and ICAO's Technical Instructions. As proposed under HM-215D, a Large Packaging consists of an outer packaging containing articles or inner packagings and designed for mechanical handling. A Large Packaging has a capacity greater than 400 kg (882 lbs.) or 450 liters (119 gallons), but does not exceed 3 cubic meters in volume. Accordingly, in this NPRM we propose to authorize Large Packagings and certain non-specification bulk containers for use as outer packagings for the transportation of RMW. Plastic film bags meeting performance and test requirements for impact and tear resistance are authorized as inner packagings for solid RMW. Inner packagings for liquid RMW must be rigid, leak resistant, puncture resistant, break resistant, impervious to moisture, and sealed to prevent leakage. In addition to the above, we propose to revise the quantity limitations applicable to shipments of RMW on aircraft. Currently, such shipments are forbidden. We propose to revise the quantity limitations for non-bulk shipments of RMW on board aircraft to read ``No limit'' for consistency with the ICAO Technical Instructions applicable to quantity limitations for RMW on airplanes. We propose to continue to prohibit bulk shipments of RMW on board aircraft. H. Used Health Care Products One commenter suggests that the HMR include an exception for used health care products. The commenter states that used health care products potentially contaminated with infectious substances, such as wound care and sanitary products, surgical equipment, diagnostic and blood testing products, and contraceptives used by consumers, medical professionals, and pharmaceutical providers are routinely returned to manufacturers. Used health care products may be returned for assessment of clinical trials, new product development, customer complaints, product investigations for government compliance, service and repair, and competitor trade-ins. The infectious status of many of these returned used health care products may not be known. An individual consumer may be unaware that he has an infectious disease or may be reluctant to reveal this information, or a patient may be infectious, but not symptomatic. In addition, patient confidentiality requirements prohibit health care providers from communicating a patient's infectious status to others. Further, in the case of potentially contaminated used health care products, it is the inanimate product that is being shipped, not the infectious agent. While used health care products may be contaminated with human blood or other body fluids or tissues, these substances usually are dried on the health care product. Special conditions necessary to promote or sustain biological integrity are not available prior to or during shipment. If infectious agents are present on used health care products, they are, in the words of the commenter, ``unwanted hitchhikers'' and are subject to hostile conditions that may inactivate pathogens over time or, at least, do not support their amplification. The commenter suggests that neither the HMR nor international standards clearly address the shipment of potentially contaminated used health care products. We agree. Thus, in this NPRM we are proposing to except used health care products being returned to the manufacturer from the requirements of the HMR provided the products are shipped in a triple packaging that conforms to certain manufacturing and marking requirements. Under this proposal, the primary and secondary containers must be marked with the OSHA BIOHAZARD symbol and must be constructed of metal or plastic in a manner that assures that they remain intact during transportation. Under this NPRM, offerors and transporters of used health care products potentially contaminated with an infectious substance must be informed about the used health care product packaging requirements. I. Hazard Communication In the ANPRM, we stated that we are considering several options with respect to the marking or placarding of bulk packagings and transport vehicles containing infectious substances, including RMW. Some commenters support a requirement for Division 6.2 placards on each vehicle or bulk packaging that contains any quantity of a Risk Group 4 infectious substance because of the extreme risks to emergency responders and the general public associated with the possible release of such material. These commenters also generally support a requirement for placards on all bulk shipments of infectious substances. Commenters who oppose placarding for shipments of infectious substances suggest that such a requirement is unnecessary, noting that there are significant differences in the potential harm that could result from a transportation incident involving infectious substances as compared to one involving flammable, toxic, or explosive materials. We agree with commenters that communication of a Risk Group 4 hazard to transportation workers and emergency response personnel is important. However, we are concerned that placarding transport vehicles containing Risk Group 4 infectious substances could compromise the security of the shipments. Further, shipments of Risk Group 4 infectious substances are strictly controlled by CDC regulation. Thus, we are not proposing a placarding requirement in this NPRM. However, we believe bulk packagings and transport vehicles containing RMW should be marked to communicate to emergency response personnel the nature of the material being transported. We are aware that a number of states and local governments have promulgated marking regulations applicable to the transportation of RMW. Many of these state and local regulations include a requirement for vehicles containing shipments of RMW to be identified with a marking similar to the BIOHAZARD symbol prescribed by OSHA regulations for containers of potentially infectious material. State, local, and tribal governments should be aware that the preemption provisions of Federal hazardous materials transportation law (federal hazmat law; 49 U.S.C. 5101 et seq.) generally preclude non-federal governments from imposing requirements applicable to hazardous materials transportation if such requirements are not consistent with the HMR. 49 U.S.C. 5125. Thus, in the absence of a waiver of preemption by the Secretary, where state or local requirements conflict with or are inconsistent with the HMR requirements, the HMR control. Federal hazmat law codifies the ``dual compliance'' and ``obstacle'' criteria for preemption of non-federal regulations. As set forth in 49 U.S.C. 5125(a), these criteria provide that, in the absence of a waiver of preemption by the Secretary [[Page 6947]] under 49 U.S.C. 5125(e) or unless it is authorized by another federal law, a requirement of a state, political subdivision of a state, or Indian tribe is explicitly preempted if: (1) complying with a requirement of the state, political subdivision or Indian tribe and a requirement of Federal hazardous materials transportation law or a regulation issued under the law is not possible; or (2) the requirement of the state, political subdivision, or Indian tribe, as applied or enforced, is an obstacle to accomplishing and carrying out Federal hazardous materials transportation law or a regulation prescribed under the law. Federal hazmat law also includes additional preemption provisions on certain ``covered subject'' areas. The covered subject areas are: (a) The designation, description, and classification of hazardous material. (b) The packing, repacking, handling, labeling, marking, and placarding of hazardous material. (c) The preparation, execution, and use of shipping documents related to hazardous material and requirements related to the number, contents, and placement of those documents. (d) The written notification, recording, and reporting of the unintentional release in transportation of hazardous material. (e) The design, manufacturing, fabrication, marking, maintenance, reconditioning, repairing, or testing of a package or container represented, marked, certified, or sold as qualified for use in transporting hazardous material. 49 U.S.C. 5125(b). Marking is a covered subject for purposes of preemption. Thus, unless authorized by another federal law or a waiver of preemption from the Secretary of Transportation, a non-federal marking requirement is preempted when it is not ``substantively the same'' as federal hazmat law or a regulation issued under it. 49 U.S.C. 5125(b)(1). In the interest of uniformity, we believe it is essential that state, local, and tribal marking requirements be consistent from jurisdiction to jurisdiction. Thus, in this NPRM, we propose to require bulk packagings containing RMW to be marked with the appropriate UN identification number. We are also proposing to require bulk packagings of RMW to be identified with a BIOHAZARD marking that conforms to OSHA specifications for the BIOHAZARD marking in 29 CFR 1910.1030(g)(1)(i). In this NPRM, we are also proposing to revise the INFECTIOUS SUBSTANCE label to reflect the new toll-free number to report infectious substances incidents to the CDC. That toll-free number is 1- 800-232-0124. J. Petitions for Rulemaking The ANPRM requested comments on a petition for rulemaking (P-1350) submitted by the Medical Waste Institute (MWI) requesting relief for transportation of waste cultures and stocks that meet the definition for Division 6.2 materials. Specifically, MWI requests that we 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. Currently, under Sec. 173.134(b)(3), the HMR allow this type of transportation for RMW that does not contain a culture or stock of an infectious substance. In support of its petition, MWI states that the current packagings required in the HMR for discarded cultures and stocks are not justified because they are expensive and lack a safety record that proves their actual public health and safety benefits. With its petition, MWI includes HMIS and state incident data on infectious substances for the period 1989 through March 1997. Experience under exemption DOT-E 11588 has","truncated":true,"body_characters":130414}