{"operation":"document","citation":"75 FR 27273","title":"Hazardous Materials; Packages Intended for Transport by Aircraft","source_type":"rulemaking","agency":"Pipeline and Hazardous Materials Safety Administration","status":"proposed","official":true,"published_on":"2010-05-14","effective_on":null,"summary":"PHMSA proposes to amend requirements in the Hazardous Materials Regulations to enhance the integrity of inner packagings or receptacles of combination packagings containing liquid hazardous material by ensuring they remain intact when subjected to the reduced pressure and other forces encountered in air transportation. In order to substantially decrease the likelihood of a hazardous materials release, the proposed amendments: prescribe specific test protocols and standards for determining whether an inner packaging or receptacle is capable of meeting the pressure differential requirements specified in the regulations and, consistent with the 2011-2012 edition of the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Aircraft (ICAO Technical Instructions), require the closures on all inner packagings containing liquids within a combination packaging to be secured by a secondary means or, under certain circumstances, permit the use of a liner.","machine_formats":{"json":"https://regulus.evalyn.ai/document/federal-register-2010-11384.json","markdown":"https://regulus.evalyn.ai/document/federal-register-2010-11384.md"},"app_url":"https://regulus.evalyn.ai/document/federal-register-2010-11384","source_url":"https://www.federalregister.gov/documents/2010/05/14/2010-11384/hazardous-materials-packages-intended-for-transport-by-aircraft","body":"Federal Register, Volume 75 Issue 93 (Friday, May 14, 2010) [Federal Register Volume 75, Number 93 (Friday, May 14, 2010)] [Proposed Rules] [Pages 27273-27284] From the Federal Register Online via the Government Publishing Office [ www.gpo.gov ] [FR Doc No: 2010-11384] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration 49 CFR Parts 171 and 173 [Docket No. PHMSA-07-29364 (HM-231A)] RIN 2137-AE32 Hazardous Materials; Packages Intended for Transport by Aircraft AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT. ACTION: Notice of proposed rulemaking (NPRM). ----------------------------------------------------------------------- SUMMARY: PHMSA proposes to amend requirements in the Hazardous Materials Regulations to enhance the integrity of inner packagings or receptacles of combination packagings containing liquid hazardous material by ensuring they remain intact when subjected to the reduced pressure and other forces encountered in air transportation. In order to substantially decrease the likelihood of a hazardous materials release, the proposed amendments: prescribe specific test protocols and standards for determining whether an inner packaging or receptacle is capable of meeting the pressure differential requirements specified in the regulations and, consistent with the 2011-2012 edition of the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Aircraft (ICAO Technical Instructions), require the closures on all inner packagings containing liquids within a combination packaging to be secured by a secondary means or, under certain circumstances, permit the use of a liner. DATES: Comments must be received by July 13, 2010. ADDRESSES: You may submit comments identified by the docket number PHMSA-07-29364 (HM-231A) by any of the following methods: Federal eRulemaking Portal: Go to http://www.regulations.gov . Follow the online instructions for submitting comments. Fax: 1-202-493-2251. Mail: Docket Operations, U.S. Department of Transportation, West Building, Ground Floor, Room W12-140, Routing Symbol M-30, 1200 New Jersey Avenue, SE., Washington, DC 20590. Hand Delivery: To Docket Operations, Room W12-140 on the ground floor of the West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal Holidays. Instructions: All submissions must include the agency name and docket number for this notice at the beginning of the comment. Note that all comments received will be posted without change to the docket management system, including any personal information provided. Docket: For access to the dockets to read background documents or comments received, go to http://www.regulations.gov or DOT's Docket Operations Office (see ADDRESSES). Privacy Act: Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78). FOR FURTHER INFORMATION CONTACT: Michael G. Stevens, Office of Hazardous Materials Standards, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue, SE., Washington, DC 20590-0001, telephone (202) 366-8553, or Janet McLaughlin, Office of Security and Hazardous Materials, Federal Aviation Administration, U.S. Department of Transportation, 490 L'Enfant Plaza, SW., Room 2200, Washington, DC 20024, telephone (202) 385-4897. SUPPLEMENTARY INFORMATION: Contents I. Background II. Problem III. ANPRM A. Studies and Data B. Pressure Differential Testing C. Alternatives to Testing D. Packaging Components IV. Summary of Proposals in This NPRM A. Incorporation of Revised ICAO TI Packaging Provisions B. Enhanced Pressure Differential Capability Standard C. Combined Enhanced Pressure Differential Capability Standard and Incorporation of Revised ICAO TI Packaging Provisions D. Vibration Testing V. Regulatory Analyses and Notices [[Page 27274]] A. Statutory/Legal Authority for This Rulemaking B. Executive Order 12866 and DOT Regulatory Policies and Procedures C. Executive Order 13132 D. Executive Order 13175 E. Regulatory Flexibility Act, Executive Order 13272, and DOT Regulatory Policies and Procedures F. Unfunded Mandates Reform Act G. Paperwork Reduction Act H. Regulatory Identifier Number (RIN) I. Environmental Assessment J. Privacy Act I. Background The Hazardous Materials Regulations (HMR; 49 CFR parts 171-180) authorize a variety of packaging types for the transportation of hazardous materials in commerce. Combination packagings are the most common type of packaging used for the transportation of both liquid and solid hazardous materials by aircraft. A combination packaging consists of one or more inner packagings or one or more articles secured in a non-bulk outer packaging.\\1\\ --------------------------------------------------------------------------- \\1\\ As a receptacle for a liquid or solid, a non-bulk outer packaging is one that has a maximum capacity of 450 liters (119 gallons) and, for solid contents, a maximum net mass of 400 kg (882 pounds). Sec. 171.8. --------------------------------------------------------------------------- Requirements for combination packagings used to transport hazardous materials are set forth in parts 173 and 178 of the HMR. Certain classes and quantities of hazardous materials may be transported in ``non-UN standard'' combination packagings, which are subject only to the general requirements in subpart B of part 173, including the following: --The packaging must be designed, constructed, filled, and closed so that it will not release its contents under conditions normally incident to transportation. Sec. 173.24(b)(1). --The effectiveness of the package must be maintained to withstand minimum and maximum temperatures, changes in humidity and pressure, and shocks, loadings and vibrations normally encountered during transportation. Sec. 173.24(b)(2). -- Each non-bulk packaging must be capable of withstanding, without rupture or leakage, the vibration test procedure specified in Sec. 178.608 of this subchapter, which sets forth a specific test method to measure the vibration capability of a non-bulk packaging. Sec. 173.24a(a)(5). A packaging authorized for transportation by aircraft must also be designed and constructed to prevent leakage that may be caused by changes in altitude and temperature. Sec. 173.27(c)(1). Inner packagings of combination packagings for which retention of liquid is a basic function must be capable of withstanding the greater of: (1) An internal pressure that produces a gauge pressure of not less than 75 kPa for liquids in Packing Group III of Class 3 or Division 6.1 and 95 kPa for other liquids; or (2) a pressure related to the vapor pressure of the liquid to be transported as determined by specified formulae. Sec. 173.27(c). A number of voluntary industry consensus standards have been developed, some of which include test methods intended to evaluate the effects of pressure differential on packagings at the various altitudes experienced in the air transport environment. These standards-setting organizations have also conducted measurement studies and testing to identify the transportation forces a package encounters and developed integrity standards and industry best-practices to ensure the pressure differential capability standard is met. This process assists all parties to design and manufacture packaging with quality standards that could be used to verify conformance with capability requirements. However, these voluntary industry standards are not included or referenced in the HMR, and the HMR do not provide specific guidance to shippers or packaging manufacturers as to how to comply with the pressure differential standards. Subparts L and M of part 178 contain UN performance standards for non-bulk packagings adopted in PHMSA's ``HM-181'' final rules in 1990 and 1991. 55 FR 52401 (December 21, 1990); 56 FR 66124 (December 20, 1991). These performance standards criteria replaced the former detailed construction specifications and provide packaging design flexibility that is not possible with detailed design specifications. The performance criteria require design qualification testing and periodic retesting to verify whether a design type meets the performance standards. For combination packagings, drop and stacking testing are required, and the packaging must be ``capable'' of passing a vibration test. Sec. Sec. 178.603, 178.606, 178.608. The packaging (including the inner packagings) must be closed for testing, and tests must be carried out on the completed package that is prepared for testing, in the same manner as if prepared for transportation. Sec. 178.602. In the HM-181 advance notice of proposed rulemaking (47 FR 16268 (April 15, 1982)) and the notice of proposed rulemaking (52 FR 16482 (May 5, 1987)), we proposed to require the hydrostatic pressure test in Sec. 178.605 to be performed on all inner packagings of UN standard combination packaging designs intended for transportation by aircraft. The pressure test would have addressed pressure differentials encountered during air transportation. This amendment was not adopted in the final rule. 55 FR 52402 (December 21, 1990). Instead, consistent with the ICAO Technical Instructions and the HMR in effect at the time, we elected to continue the requirement for all packagings containing liquids offered or intended for transportation aboard aircraft to be capable of withstanding without leakage a specified pressure differential. Sec. 173.27(c). Since that time, ICAO has added a note to Part 4; 1.1.6 of the Technical Instructions stating that the capability of a packaging to meet the pressure differential performance standard should be determined by testing, with the appropriate test method selected based on packaging type. However, ICAO has not adopted specific test methods in the Technical Instructions. Because the HMR do not specify test methods for verifying that a packaging meets the pressure differential requirement, some shippers and packaging manufacturers have used historical data (i.e., lack of incidents) and other methods (e.g. computer modeling, analogies, or engineering studies) to demonstrate that their packagings satisfy the pressure differential capability requirement. Shippers and packaging manufacturers have differing views on how the requirements are to be verified, and use various test methods to demonstrate compliance. This leads to a non-uniform approach, and it is difficult for PHMSA and FAA to verify whether a package meets the pressure differential requirement because no test report, documentation, or other proof of compliance is required by the HMR. Additionally, it does not provide an effective method of oversight to determine whether regulatory requirements are meeting actual forces encountered in transportation. If there is no control, the evaluation of quality and failure analysis is not possible. Even the most conscientious and safety-focused shippers have difficulty understanding how to comply with the requirements in Sec. 173.27. Other shippers and packaging manufacturers may be taking advantage of the absence of specific requirements for verifying compliance. The absence of specific test methods in the HMR leads to inconsistencies in package integrity and results in varying levels of compliance among shippers. References to the pressure differential requirements in Sec. 173.27(c) are found throughout the regulations for packagings and packages offered for air transportation and transported by [[Page 27275]] aircraft without methods specified to verify compliance with this critical safety requirement. This results in wide disparities in packaging quality and the potential for sub-standard packages to be introduced into the air transport environment, increasing the probability of releases of hazardous materials aboard aircraft. In addition, some shippers or manufacturers may not realize that inner packagings of non-UN standard combination packagings are required to meet the pressure differential capability requirements of the HMR and the ICAO Technical Instructions. This includes packagings authorized under the limited quantity, consumer commodity, and Category B Biological Substance exceptions. A significant percentage of aircraft incidents involving liquid hazardous materials appear to result from failures of these packagings. We strongly believe the introduction of specific test methods and amendments that clarify the requirements for packagings offered for transportation by aircraft will enhance safety by reducing risk and level the playing field for shippers, manufacturers and air carriers alike. II. Problem When a package reaches high altitudes during transport, it experiences low pressure on its exterior. This results in a pressure differential between the interior and exterior of the package since the pressure inside remains at the higher ground-level pressure. Higher altitudes create lower external pressures and, therefore, larger pressure differentials. This condition is especially problematic for combination packagings containing liquids. When an inner packaging, such as a glass bottle or plastic receptacle, is initially filled and sealed, the cap must be tightened to a certain torque to obtain sealing forces sufficient to contain the liquids in the packaging. This will require certain forces to be placed upon the bottle and cap threads as well as the sealing surface of the cap or cap liner to ensure the packaging remains sealed. Once at altitude, due to the internal pressure of the liquid acting upon the closure combined with the reduced external air pressure, the forces acting on the threads and the forces acting on the sealing surfaces will not be the same as when the packaging was initially closed. Under normal conditions encountered in air transport (26 kPa reduction in pressure at 8000 ft), the pressure differentials are not overly severe. However, if the compartment is depressurized at altitude or if the compartment is not pressurized at all, such as on certain ``feeder'' aircraft, the pressure differential may be severe enough to cause package failure and release of the hazardous materials in the aircraft. High-altitude stresses are encountered when cargo and feeder aircraft transport packages in non- pressurized or partially-pressurized cargo holds. A seemingly ``minor'' incident can quickly escalate and result in irreversible, possibly catastrophic, consequences. For example, a closure failure of an inner container could cause an outer package to fail, resulting in fumes, smoke or flammable liquid acting as a catalyst to a more serious incident. The interaction of events occurring on aircraft, such as electrical fires, static electricity or other materials interacting with the leaking material, could result in a catastrophic event. The successful testing of inner packaging designs may lower the likelihood of such an event. Taking a systems-safety approach that includes multiple safety processes and redundancies can prevent a minor incident from becoming potentially much worse. PHMSA, FAA and, more recently, several international competent authorities all agree that the testing of design samples or prototypes of inner packagings or receptacles for pressure differential capability is key to preventing package failure in air transport. Testing also forms the basis of current performance standards in both the HMR and international regulations. Additionally, incident data and compliance verification testing of combination packagings intended for air transport and readily available in the marketplace indicate that an unacceptable number of packagings are not able to withstand pressure differential conditions normally incident to air transportation. Again, the packagings of particular concern are packagings that must be ``capable'' of meeting pressure differential requirements, but are not required to be certified as meeting a specific performance test method to verify compliance with pressure differential performance standards. Incident data continue to show that packagings are leaking aboard aircraft; this likely is in part attributable to the fact that the HMR do not specifically provide test methods for determining that packagings meet the minimum pressure differential performance necessary to withstand conditions of air transport. It cannot be overemphasized that any incident, such as a package failure, involving hazardous materials in air transportation is unacceptable. Four recent studies simulated the impact of high-altitude on package integrity. These conditions result in extreme changes in pressure when compared to packages being transported at or close to sea level. These four studies were discussed in detail in the ANPRM published under this docket [73 FR 38361; July 7, 2008] and are available for review at http://www.regulations.gov . In the first study, FAA analyzed incident data from the DOT Hazardous Materials Information System (HMIS) for the years 1998 and 1999 and focused on properly declared hazardous material shipments. The study concluded that of 1,583 air incidents reported to PHMSA, a failure of inner packagings in combination packaging designs contributed to 333 spills or leaks. In the second study, United Parcel Service (UPS) presented its findings to the American Society of Testing and Materials (ASTM) outlining the conditions that packages experience in the air transport environment. In 2002, the FAA initiated a study with Michigan State University (MSU) to replicate actual air and pre- and post-truck transportation conditions to determine which conditions contribute to package failures. In this third study on conditions experienced in air transportation, FAA examined the effects of vibration alone, altitude alone, and a combination of vibration and altitude on the performance of UN standard hazardous material combination packages containing liquids. In 2003, PHMSA also initiated a study with MSU to compare the HMR requirements and the testing used in the FAA/MSU study to provide for a more thorough evaluation of the performance of liquid hazardous materials in combination packagings when subjected to the conditions of air transport. This fourth round of testing was conducted on a smaller number of packaging designs; however, a much greater number of packagings of each design were tested in the study. During the first half of 2007, PHMSA conducted a comprehensive assessment of hazardous materials transportation incidents occurring in air transportation from 1997 through 2006. This study and its corresponding data may be accessed in the public docket for this rulemaking. The study concluded that there has been no appreciable reduction in package failures over the past 10 years. It is estimated that 191,429 tons of liquid hazardous materials contained in approximately 16.9 million combination packages are transported by aircraft annually. Of that total, the analysis concluded that approximately 483 combination packagings containing liquids fail in air transportation each [[Page 27276]] year with an average of two incidents reported as ``serious.'' \\2\\ However, any incident, such as a package failure, involving hazardous materials in air transportation is unacceptable. --------------------------------------------------------------------------- \\2\\ The HMR define a ``serious incident'' as one that involves one or more of the following: (1) A fatality or major injury caused by the release of a hazardous material; (2) the evacuation of 25 or more persons as a result of release of a hazardous material or exposure to fire; (3) a release or exposure to fire which results in the closure of a major transportation artery; (4) the alteration of an aircraft flight plan or operation; (5) the release of radioactive materials from Type B packaging; (6) the release of over 45 liters (11.9 gallons) or 40 kilograms (88.2 pounds) of a severe marine pollutant; or (7) the release of a bulk quantity (over 450 liters (119 gallons) or 400 kilograms (882 pounds)) of a hazardous material. Sec. 171.15. --------------------------------------------------------------------------- The 2007 study concluded that of the approximately 483 air incidents reported each year, at least 44 percent involved the failure of inner packaging closures within a combination outer packaging as the primary cause. Such failures could have been the result of pressure differential (packages closed at sea level subjected to lower pressure on planes), stress relaxation of the closure (closures that appear tight but loosen during transportation), improper closures, vibration, or some other cause. The analysis also suggested that most incidents involved combination packagings containing flammable liquids (e.g., paint and paint related material) of varying degrees of hazard. Some additional statistical data from the 2007 incident review include: Over 40% of failures of combination packages containing liquids in air transportation involve closures and/or inner receptacles. Flammable liquids are the most common liquid hazardous materials released from failed packages in air transportation. If such materials found an ignition source, it could result in a fire or explosion. In incident years 2005-2006, 18 of 953 incidents involving combination packagings containing liquids, or 2%, occurred on passenger-carrying aircraft. Although low when compared to incidents occurring on cargo-carrying aircraft, this percentage of package failures continues to be a troubling statistic. Combination packages containing liquids that fail in air transportation release an average 2 liters (0.5 gallons) of liquid hazardous materials. III. ANPRM On July 7, 2008, PHMSA published an advance notice of rulemaking (ANPRM; 73 FR 38361) seeking to identify cost-effective solutions to reduce incident rates and the potential severity of incident consequences without placing unnecessary burdens on the regulated community. We solicited comments on how to accomplish these goals, including measures to: (1) Enhance the effectiveness of performance testing for packagings used to transport hazardous materials on aircraft; (2) more clearly indicate the responsibilities of shippers that offer packages for air transport in the HMR; and (3) authorize alternatives for enhancing package integrity. We asked a series of questions related to the packaging of liquid hazardous materials in combination packagings that are offered for transportation and transported by aircraft. A total of 13 persons submitted comments in response to the ANPRM; the list of commenters includes: AHS Association of Hazmat Shippers, Inc. Ecolab Ecolab, Inc. ALPA Air Line Pilots Association, International COSTHA The Council on Safe Transportation of Hazardous Articles, Inc. IOPP Institute of Packaging Professionals CPC Chemical Packaging Committee FedEx Federal Express ISTA International Safe Transit Association ASTM ASTM International ICC ICC The Compliance Center, Inc. MSU Michigan State University School of Packaging Viking Viking Packing Specialist DGAC Dangerous Goods Advisory Council Commenters generally agree that regulatory changes are necessary to address safety issues related to the transportation of hazardous materials in non-UN standard packagings on board aircraft. However, commenters had varying views on the scope of the safety problem or specific regulatory amendments necessary to eliminate or reduce problems should they exist. Some commenters also questioned the validity of studies conducted and analysis of the underlying data used that motivated PHMSA to initiate rulemaking action. These comments are summarized below. A. Studies and Data As indicated previously, recent studies have simulated the impact of high altitudes on packaging integrity. These studies suggest that the current testing requirements (or lack thereof) under the HMR may not adequately address the conditions encountered during air transportation. Moreover, a review of incident data conducted by FAA and PHMSA supports the conclusion that some combination packaging designs used to transport hazardous materials by aircraft may not meet the capability standards mandated under the HMR. Indeed, the testing conducted suggests that the capability standards themselves may not be sufficiently rigorous to ensure that packagings maintain their integrity under conditions normally incident to air transportation. Study data, incidents, and several years of feedback from industry indicate that, without specific standards and protocols, a consistent approach to compliance cannot be achieved. This can lead to a potentially unsafe condition. Some commenters cited concerns over how two of the studies were conducted or suggested that the problems discussed in the ANPRM may not be as serious as presented. For example, Ecolab identifies what it contends are at least three discrepancies in the two air packaging integrity studies conducted by MSU in 2002 and 2003 on behalf of PHMSA and FAA. Ecolab contends that these discrepancies, identified by CPC and published in a 2006 Hazmat Packager and Shipper article, occurred because some of the tests utilized for the studies were not conducted in accordance with the HMR or corresponding international standards. One study allegedly used an improper closure design that differed from the originally tested design. CPC asserted that the improper closure design used in the study raised the number of packaging failures from 14 to 42, an increase of 75%. In its comments, Ecolab contends that a successfully tested package will not leak when closed properly and subjected to normal conditions of air transport. As a result of conclusions drawn from these initial studies and to address challenges made to the assumptions used in their methodology, further studies were budgeted and carried out. PHMSA and FAA acknowledge that some of the studies utilized packagings that did not conform in all respects with HMR requirements. The characteristics of the packagings tested were fully disclosed in the study reports. We do not agree that the minor differences in the closures used affects the conclusions of the studies. We note that the studies were not used to determine compliance with HMR requirements, but rather to measure the capability of commercially available packaging designs to withstand the unique conditions encountered in air transportation. Although most commenters support the actual testing of inner packaging designs for pressure differential capabilities, several commenters doubt that incidents are occurring in air transport as a result of the lack of actual testing. AHS notes that incident reports submitted to PHMSA in accordance with reporting requirements in Sec. 171.16 of the HMR do not indicate whether an inner packaging failed because it had [[Page 27277]] not been tested or because it was not capable of withstanding forces encountered in transportation. We note that it is highly unlikely that a carrier or other entity without intimate knowledge of a packaging's design or overall integrity would be able to report, as a root cause, that an incident that occurred in air transportation resulted from a lack of actual testing or the packaging's inability to withstand the forces inherent to transportation by aircraft. However, by carefully analyzing available incident data and conducting controlled laboratory studies of commercially available packaging designs, we can conclude that the actual testing for pressure differential capability was either conducted incorrectly or not conducted at all. COSTHA contends that PHMSA should not be alarmed if leakage from an inner packaging is contained within its outer packaging and suggests that seepage from a closure over time should be evaluated differently than a complete failure where the entire contents of an inner packaging are released within an outer packaging. We disagree. A successfully tested and properly filled and closed inner packaging design should not leak under normal conditions encountered in air transportation. Additionally, an inferior inner packaging design or component would be identified through the pass/fail criteria when originally tested. Because the primary receptacle within a combination packaging system is the most important component of that system in air transport, it should not fail except under extreme or highly abnormal conditions. Regarding the distribution hazards experienced in today's air transport environment, Ecolab asserts that shipments have always been subjected to multiple flight segments and any consequences resulting from that environment. Ecolab is correct; however, although shipments have routinely utilized multiple flight segments in the past, the proliferation of sort systems and feeder aircraft systems has changed the environment shipments normally encountered during transit. Today, air carriers use multiple mechanical handling systems to sort packages, and the number of distribution points has grown with the natural expansion of commerce. In its comments, Ecolab states that better enforcement of existing regulations related to packaging integrity is key to reducing the number of incidents in air transportation. We agree. Once verifiable and repeatable testing standards are adopted in the HMR, shippers, packaging test labs, and government regulators can all measure packaging integrity using the same process, procedures, and protocols. Consistency is the most efficient and effective way to measure success or failure. Ecolab also notes that, according to PHMSA's HMIS incident database, human error is cited as an accident cause six times more frequently than packaging failure. An example of human error could be the deliberate or inadvertent consequences resulting from failure to follow a packaging manufacturer's customer notification or closure instructions. An example of packaging failure would be differences in manufacturing tolerances that result in leakage (failure) from an otherwise properly closed inner packaging design. Again, this supports the multi-layered safety system concept. B. Pressure Differential Testing In the ANPRM, we noted that because specific test methods are not included in the HMR or the ICAO Technical Instructions, there are inconsistencies in package integrity and varying levels of compliance among shippers. For example, because the pressure differential and vibration capability standards for combination packagings are not required to be verified by test protocols, some shippers (self- certifiers) or manufacturers have used historical shipping data, computer modeling, analogies to tested packagings, engineering studies, or similar methods to determine that their packagings meet pressure differential and vibration capability standards. Shippers, carriers, packaging manufacturers, and testing facilities generally agree that the current capability requirements for air packagings are difficult to comply with and suggest that specific test methods designed to demonstrate that packagings will withstand conditions encountered during air transportation should be specified in the HMR. Ecolab states that the current regulatory language in the HMR regarding the pressure differential capability of inner packagings should be replaced with recognized industry standards for testing and no additional testing should be proposed. ALPA recommends that the HMR incorporate the language contained in the ICAO Technical Instructions clarifying test methods and responsible parties. For example, the ICAO Technical Instructions suggest test methods appropriate for certain types of inner packagings and liquid hazardous materials in order to promote compliance with the prescribed performance standard. ALPA contends the lack of standardized, easily understandable testing protocol contributes to incidents in air transportation. Ecolab and Viking both agree that, to properly determine the capability of a packaging design, it must first be tested. ISTA asserts that the simultaneous combination of low pressure and vibration exerted on a package is the only way to accurately replicate conditions encountered by a package in air transportation. The HMR and ICAO Technical Instructions both require that a shipper consider the pressure differential capability for an inner packaging intended to contain a mixture or solution based on its vapor pressure. Many commenters agree that determining the vapor pressure of a mixture or solution is problematic, costly, and does not materially contribute to reducing the likelihood of packaging failure. Ecolab believes that a 95 kPa differential capability is a realistic and attainable indication of inner packaging integrity and that the 75 kPa capability for some hazard classes and packing groups should be eliminated for clarity and increased safety. In addition, Ecolab states that PHMSA should codify any testing protocol adopted in Subpart M of Part 178. Because the proposed amendments in this notice apply to non-UN standard packagings as well as UN standard packagings, and the Part 178 requirements apply to UN standard packagings only, it is appropriate that the amendments proposed in this notice be codified in Sec. 173.27. We appreciate and understand commenter frustration with regard to calculating the vapor pressure of a mixture or solution to determine the appropriate packaging capable of withstanding the prescribed pressure differential. In this NPRM, we are proposing an alternative method that can be used to calculate the appropriate packaging required for a mixture or solution without testing to determine vapor pressure. C. Alternatives to Testing The HMR and ICAO Technical Instructions both allow a liquid hazardous material to be contained in an inner packaging that does not itself meet the pressure differential performance standard, provided that the inner packaging is packed within a supplementary packaging that does meet the pressure requirements. In their comments, AHS and ICC ask PHMSA to retain in the HMR the option for a shipper to use supplementary packaging that meets the pressure differential requirements. PHMSA agrees with commenters on this issue and is not [[Page 27278]] proposing to amend the HMR to do otherwise. The HMR currently permit the use of variations in inner packagings of a tested combination package, without further testing of the package, provided an equivalent level of performance is maintained under conditions prescribed in Sec. 178.601. ICC states that a packaging designed to successfully withstand the Sec. 178.601(g)(2) Variation 2 test protocols should not be required to contain inner packagings capable of meeting the pressure differential and vibration capabilities of the HMR. We disagree. A primary inner packaging or receptacle of known or questionable inferiority is unacceptable in air transportation regardless of whether the outer packaging is of a higher integrity. No other commenters opposed actual testing of inner packagings of combination packagings intended to contain liquids for transportation by aircraft. ICAO recently adopted revised packaging instructions for incorporation in the ICAO Technical Instructions that will become effective January 1, 2011. The new packing instructions require a secondary means of closure for all liquids in combination packagings. This requirement may be satisfied by using a liner or other form of containment when the secondary means of closure cannot be applied. Inner packagings containing liquids of Packing Group I must be placed in rigid leakproof receptacles with absorbent material before placing them in outer packagings of a combination package. None of the comments submitted to the ANPRM oppose this requirement; those who did comment on this requirement support its adoption in the HMR. D. Packaging Components Many commenters state that pressure differential and vibration capability standards should apply to both specification and non- specification packaging designs. Ecolab asserts that a properly tested and closed inner packaging design offers no risk in air transport. In evaluating the inherent risks assumed in air transportation and the potential for high consequence events should an incident occur, ALPA supports multiple layers of redundancy to include actual testing of inner packaging designs and the use of liners, absorbent material, and secondary means of closure. Commenters agree that the interaction between an inner packaging containing a liquid and its closure are critical in air transport. COSTHA believes that if any component of a tested design is changed, and it is not an exact replacement, quality review and testing is required. Viking believes that a successfully tested inner packaging is only one (albeit a major one) part of a closure system that also uses a protective liner and is properly oriented when stored or transported. PHMSA and FAA both agree that the verification of packaging integrity through testing and the additional redundant amendments proposed in this notice will ensure consistency in the quality of packagings used for the air transport of liquid hazardous materials and mitigate or eliminate the consequences of an incident or accident should one occur. IV. Summary of Proposals in This NPRM Because aircraft accidents caused by leaking or breached hazardous materials packages can have significant or catastrophic consequences, the air transportation of hazardous materials requires clear standards, exceptional diligence, and attention to detail. To address the regulatory deficiencies previously described in detail, we are proposing amendments to the HMR to strengthen the integrity of packages intended for transport by aircraft. Most commenters support adoption of the ICAO Technical Instructions requirement for a secondary means of closure and utilization of a liner if such secondary means of closure is infeasible or impracticable. Further, most commenters agree that the most effective means to ensure that combination packagings are capable of meeting specified performance standards is actual testing. We agree. Therefore, in this NPRM we are proposing to adopt the new ICAO Technical Instructions requirements for combination packagings and test protocols that may be used to demonstrate that such packagings conform to applicable performance standards. If adopted, these amendments will add clarity to the processes required in determining whether a packaging design is capable of meeting the forces encountered in air transportation. We are confident that these enhancements to current regulatory requirements will result in a higher level of safety in air transportation by reducing the likelihood of combination package failures in air transportation. The following is a summary of the proposals in this NPRM. A. Incorporation of Revised ICAO Technical Instructions Packaging Provisions Currently under the HMR, stoppers, corks, or other such friction- type closures must be held securely, tightly, and effectively in place by positive means. See Sec. 173.27(d). However, a screw-type closure on any packaging must only be secured to prevent the closure from loosening due to ``vibration or substantial change in temperature.'' We have stated in letters of clarification that a secured closure should incorporate a secondary means of maintaining a seal, such as a shrink","truncated":true,"body_characters":79876}