PHMSA catches up on harmonisation

BETTER LATE THAN NEVER

USA • THE HAZARDOUS MATERIALS REGULATIONS HAVE BEEN BROUGHT INTO LINE WITH INTERNATIONAL PROVISIONS – BUT THAT HARMONISATION WILL NOT LAST FOR LONG

THE PIPELINE AND Hazardous Materials Safety Administration (PHMSA) has published its final rule under HM-215P, its biennial international harmonisation rulemaking. The final rule reflects comments and revisions following the publication of a notice of proposed rulemaking (NPRM) as far back as August 2021; its finalisation has been held up by a combination of addenda and corrigenda to the international provisions as well as domestic developments in terms of the Covid-19 response and the Biden administration’s ambitions for reductions in greenhouse gas emissions.

PHMSA is also catching up after the years of the Trump presidency, when new regulation was frowned upon and it had to struggle to persuade its political masters that the changes it proposed were really necessary. It should be remembered that, while international harmonisation is a good thing as far as corporations with international operations are concerned, there are a lot of dutyholders under the provisions of the US Hazardous Materials Regulations (HMR) that only operate domestically (sometimes only intra-state) and for whom international harmonisation is moot. Such parties may see the regular amendments to HMR as being irrelevant to them and merely generating additional costs.

HM-215P is retrospectively effective as from 1 January 2021, concurrent with the international provisions to which it seeks to harmonise: Amendment 40-20 of the International Maritime Dangerous Goods (IMDG) Code, the 2021-2022 edition of the International Civil Aviation Organisation’s (ICAO) Technical Instructions and the 21st revised edition of the UN Model Regulations. The changes contained in HM-215P took effect on 25 August 2022 and compliance will be mandatory as from 26 July 2023.

This brief review of what is a very lengthy rulemaking covers some of the more significant changes; dutyholders can find the full final rule in the Federal Register at www. federalregister.gov/ documents/2022/07/26/2022-15358/ hazardous-materials-harmonization-withinternational-standards.

INS AND OUTS While PHMSA aims for harmonisation with international regulations, and despite the US having the chair of the UN Sub-committee of Experts that agrees the amendments to the UN Model Regulations, it nevertheless retains the right to vary from those provisions, either because the issues covered are already addressed in HMR or because it feels that the new amendments adopted do not address a

THE US AIMS FOR INTERNATIONAL HARMONISATION

BUT ALSO HAS ITS OWN WAY OF DOING QUITE A LOT

pressing safety issue. It is, therefore, often most relevant for those doing business into and out of the US to examine those areas where HMR is not in alignment with international provisions.

One the other hand, the harmonisation rulemaking does give PHMSA the opportunity to introduce provisions designed to deal with emerging technologies and hazards. For example, in its preamble to HM-215P, PHMSA says the final rule will “improve the safe transportation of vaccines and other medical materials associated with the ongoing response to the … Covid-19 public health emergency, or any similar public health emergency that may emerge, by removing unnecessary regulatory hurdles to the international movement of those materials”.

Similarly, PHMSA notes that the final rule also aligns the requirements in HMR with “anticipated increases in the volume of lithium batteries transported in interstate commerce from electrification of the transportation and other economic sectors”.

Bearing in mind that many of the amendments contained in HM-215P derive from revisions to the UN Model Regulations adopted nearly three years ago and may be fading from memory, it is probably worth examining them in some detail.

To begin with the easy stuff, the final rule includes newer incorporations by reference, involving not only the revised editions of the UN Model Regulations, IMDG Code and ICAO Technical Instructions but also the International Atomic Energy Agency’s (IAEA) Regulations for the Safe Transport of Radioactive Material, 2018 edition (SSR-6, Rev 1), several new or updated standards published by the International Organisation for Standardisation (ISO) and an updated version of the Organisation for Economic Cooperation and Development (OECD) Guidelines for the Testing of Chemicals, Test No 431: In vitro skin corrosion; reconstructed human epidermis (RHE) test method.

In addition to harmonisation, PHMSA keeps an eye on what is going on north of the border, given that there is so much cross-border traffic involving dangerous goods. HM-215P includes a revision in §171.12(a)(1) to authorise the transport by road or rail of a hazardous material in the US under a temporary certificate issued under the terms of Canada’s Transportation of Dangerous Goods (TDG) Regulations. This follows up on earlier work to enhance cross-border transport and reflects the fact that Transport Canada already recognises special permits issued by PHMSA for transport operations in Canada.

CLASSIFICATION AND LISTING PHMSA has brought in a range of amendments and additions to the Hazardous Materials Table (HMT) in §172.101. These include the introduction of three entries for electronic detonators (UN 0511, 0512 and 0513) and UN 3549 Medical waste, Category A, solid, newly adopted by the UN Model Regulations.

PHMSA proposed assigning special provision 131 to UN 3549 to specify that special permits are required for use of this entry. The Dangerous Goods Advisory Council (DGAC) and the Healthcare Waste Institute (HWI) had opposed this, calling for the assignment of internationally recognised packaging provisions and the production of guidance to allow an immediate, safe and compliant packaging solution. PHMSA demurred, however, noting that the unknown nature of any infectious agent that may produce a Category A biological waste makes it necessary to retain greater oversight of the safety and operational controls associated with approved packagings via the special permit process. It is sticking with its original proposal to assign SP 131 to UN 3549. It has, however, added a clarifying special provision 430, reading:

This entry shall only be used for solid medical waste of Category A transported for disposal.

Again following the international lead, and to keep up with modern technology, PHMSA is adopting provisions for lithium batteries in equipment that are attached to or contained in packagings (including large packagings, intermediate bulk containers (IBCs) or cargo transport units) and intended for use or in use during transport, such as ‘data loggers’. These provisions are found in a new §173.14, which provides exemptions from HMR for such equipment, with the proviso that the equipment meets conditional safety requirements. The text as originally proposed has been amended to clarify that it does not cover such equipment when it is being offered as cargo.

The amendment is consistent with provisions adopted in the UN Model Regulations and IMDG Code. Subsequent to the publication of those documents, ICAO responded to the Covid-19 emergency by

adding a limited exception for data loggers and cargo tracking devices to facilitate the distribution of vaccines and other pharmaceuticals. As such, PHMSA has extended the exceptions in §173.14 to cover all transport modes, although for air transport there are limitations, specified in §173.14(b):

For transportation by aircraft, lithium batteries contained in equipment such as data loggers and cargo tracking devices, attached to or placed in packages containing COVID-19 pharmaceuticals, are not subject to the marking and documentation requirements of § 173.185(c) (3) and (c)(4)(iv). This same package, when shipped without the COVID-19 pharmaceuticals for the purpose of use or reuse, is also not subject to the marking and documentation requirements of § 173.185(c)(3) and (c)(4)(iv), as applicable, provided prior arrangements have been made with the operator.

There were some adverse comments to PHMSA’s proposals for §173.14, with some noting that it contradicts a letter of interpretation that industry has relied on for several years, including in the shipment of hearing aids, defibrillators and implantable devices. In response, a paragraph (c) has been added for clarification:

The exception provided by this section does not apply to hazardous materials shipped as cargo. Hazardous materials contained in equipment as described in this section, when transported as a cargo, are subject to, and must be transported in accordance with, all applicable requirements of this subchapter.

PHMSA has also responded to action by ICAO to allow the transport of stabilised fish meal or fish scrap (UN 2216) by air. This trade has until now been restricted to seagoing transport but, in response to increased demand for timely shipment and in recognition of improved methods of stabilisation, PHMSA is mirroring the requirements in the latest ICAO Technical Instructions. Revisions to §173.218 now permit the shipment of UN 2216 material on passenger and cargo aircraft in volumes up to 100 kg and 200 kg, respectively, in UN performance packaging. Fish meal or fish scrap transported by air must have been stabilised at production, and within the twelve months prior to transport.

PACKAGING CHANGES PHMSA has followed the UN Model Regulations in removing the minimum wall thickness for metal IBCs with a capacity of 1,500 litres or less. This appears in §178.705(c)(1)(iv) and is, PHMSA suspects, a holdover from the days when metal IBCs were treated in the same way as tank containers. This change, which did not generate any adverse comments, will provide additional flexibility in terms of design and construction, PHMSA says, while preserving the expected level of safety.

The Reusable Industrial Packaging Association (RIPA) took the opportunity to ask PHMSA whether a broader review of IBC construction would be worthwhile, given the wide variety of designs and materials used as well as the very different materials being shipped in IBCs. PHMSA invited RIPA to submit a petition for rulemaking, along with data and arguments.

PHMSA followed ICAO’s lead in revising the packing requirements for UN 2211 Polymeric beads, expandable and UN 3314 Plastic molding compound, transport of which has thus far been restricted to single packagings. That restriction is inconsistent with the UN Model Regulations and also conflicts with general provisions in the ICAO Technical Instructions that permit combination packagings whenever single packagings are authorised. PHMSA determined that a similar position exists in HMR and has therefore revised §173.221 to allow the use of combination packagings for these products.

PHMSA has also decided to extend the periodic inspection period for cylinders used for fire extinguishing agents transported as UN 3500 Chemicals under pressure, nos. This follows the adoption in the UN Model Regulations of a new special packing provision, PP97, that provides a test period of ten years for tubes (cylinders) that have a capacity of 450 litres or less and that are filled with fire extinguishing agents. This resolves a discrepancy in the regulations, as UN 3500 cylinders previously had a five-year inspection period, whereas gases transported under UN 1956 Compressed gas, nos were given ten years. This seemed odd, as UN 3500 materials are typically inert and filled at a lower pressure than UN 1956 gases.

Meanwhile, PHMSA had earlier made changes to allow some hazardous materials transport in cylinders under UN 1956 or 3500 to be classified as UN 1044 Fire extinguisher. This is not in alignment with the UN Model Regulations, where UN 1044 is not supposed to be assigned to cylinders

intended for use in fixed fire suppression systems. PHMSA says that items of UN 3500 and 1044 are “functionally the same” but classified differently in the US and internationally. Nevertheless, the alignment of periodic inspection intervals in §173.335 will at least facilitate international movement of these cylinders.

LITHIUM BATTERIES PHMSA is amending several provisions pertaining to the transport of lithium batteries, including minimum size markings and the modification of stowage requirements for lithium batteries, including those offered as damaged/defective or for disposal/recycling. One change it is not making is to copy over the Note in special provision 376, which provides guidance on whether a lithium battery is damaged or defective: while PHMSA acknowledges that some guidance is needed, it feels that the non-prescriptive language used in SP 376 is not appropriate for HMR and, instead, it has issued a safety advisory notice that cites the UN guidance.

In addition, a new §172.203(i)(4) requires shipments of lithium batteries that are offered into transportation for purposes of disposal or recycling or offered under the damaged or defective provisions in §173.185(f), to indicate on shipping papers one of the following disclaimers, as appropriate: “DAMAGED/ DEFECTIVE,” “LITHIUM BATTERIES FOR DISPOSAL,” or “LITHIUM BATTERIES FOR RECYCLING”. This is consistent with the IMDG Code.

Unlike other regulatory systems, the US HMR covers all modes of transport and HM-215P includes a number of amendments specific to the stowage of hazardous materials aboard vessels. One of these is the addition of stowage code 156 to the main lithium battery entries (UN 3090, 3091, 3480 and 3481). This code requires that lithium batteries that are offered in transport for disposal or recycling, or that are offered under damaged, defective, or recalled provisions must be stowed on deck only, rather than on or under deck, as is the case with regular batteries.

One UN change that was adopted is the assignment of special provision 360 to UN 3481 and 3091; SP 360 clarifies that vehicles powered solely by lithium batteries must be assigned to UN 3171, rather than to one of the ‘lithium batteries contained in equipment’ entries. SP 360 has also been revised to better distinguish between the various types of equipment with lithium batteries, in particular to specify that lithium batteries that are installed in cargo transport units and designed only to provide power external to the transport unit must be transported as UN 3536 Lithium batteries installed in a cargo transport unit, making them subject to packaging provisions and exceptions outlined in SP 389.

Special provision 134 has been revised to clarify its scope as regards UN 3171 (batterypowered vehicles and equipment) and UN 3536. The amendment does not make any substantive changes but should make SP 134 easier to apply.

There are some minor changes to the minimum size of the lithium battery mark on smaller packagings containing lithium cells or batteries in §173.185, bringing it into line with the existing minimum size requirements for limited and excepted quantities.

OTHER ISSUES PHMSA is amending §§172.203(l) and 172.322 to limit the applicability of requirements for specific marine pollutant constituents for generic entries (indicated by the letter ‘G’ in column 1 of the Hazardous Materials Table) and those containing ‘nos’ as part of the proper shipping names. This maintains alignment with the IMDG Code. This new exception in special provision 274, specifically for UN 3077 and 3082 material, allows the use of a proper shipping name found in the Dangerous Goods List in place of a technical name, provided it is not an ‘nos’ entry and is not assigned to SP 274. This relief was provided largely in response to an appeal from the paint industry.

In addition, a new SP 441 provides the same shipping description flexibility specifically for marine pollutants by removing the requirement to supplement the proper shipping name associated with UN 3077 and 3082 with a technical name. These amendments aim to provide flexibility regarding documentation and marking requirements, which currently require identifying the technical names of marine pollutant components in those materials.

The other main change in HM-215P concerns new stability testing requirements for nitrocellulose, which is derived from

amendments in the UN Model Regulations that were agreed only after lengthy deliberation. The key to this change can be found in the new special provisions 196 and 197; SP 196 applies to Class 1 materials shipped as UN 0340, 0341, 0342 or 0343; SP 197 is assigned Class 4 materials shipped as UN 2555, 2556, 2557 or 3380. SP 196 specifically removes the requirement for a Type 3(c) thermal stability test.

These special provisions are intended to ensure nitrocellulose products are tested to verify they meet specific stability requirements to avoid the danger of self-ignition during transport. They require that the material meets the criteria of the Bergmann-Junk test or the methyl violet paper test, as specified in the UN Manual of Tests and Criteria.