In its most significant rulemaking in some time, the Pipeline and Hazardous Materials Safety Administration (PHMSA) published HM-219C, intending to reduce regulatory burdens. This was made in response to petitions by shippers, carriers, manufacturers and industry representatives. 

The Final Rule takes effect on December 28, 2020.

This final rule, published November 25, 2020, updates, clarifies, or provides relief from various regulatory requirements without adversely affecting safety. Effective December 28, 2020, and with a few exceptions, compliance with the amendments adopted is delayed until November 26, 2021. PHMSA also withdraws its September 28, 2017 enforcement discretion regarding the phase-out of mobile refrigeration systems, effective December 28, 2020.

Key Updates PHMSA Adopted:

• Makes limited quantity exceptions available for more than 100 corrosive materials on the Hazardous Materials Table 172.101 to align with international regulations.

• Provides flexibility for cleaning metal drums for reuse and clarifies the existing standard under 49 CFR 173.28(c)(1)(i).

• Revises 49 CFR 173.5b to allow the continued use of portable and mobile refrigerator systems in service prior to 1991 rated to a minimum of 250 psig.

• Allows non-RCRA waste materials to be packed under the lab pack exception of 49 CFR 173.12 irrespective if they meet the hazardous waste definition.

• Revises 49 CFR 172.101(c) clarifying the word “stabilized” to be added to certain Proper Shipping Names to agree with IMDG code naming requirements.

• Revises requirements for poison-by inhalation (PIH) materials by rail after 12-31-20.

• Incorporates by reference updated versions of multiple Compressed Gas Association (CGA) publications.

The Final Rule also makes technical corrections and incorporates updated editions of various publications in the Hazardous Materials Regulations (HMR).

Preparing the COVID-19 Vaccine Trail…

As stated in the Dec. 1 U.S. DOT press release, U.S. Department of Transportation is Preparing the Way for Swift COVID-19 Vaccine Transport, the ‘FAA COVID-19 Vaccine Air Transport Team’ was established in October as part of the DOT’s effort to support the safe and expedited transportation and distribution of approved COVID-19 vaccines. Coordination with the Pipeline and Hazardous Materials Safety Administration (PHMSA) has been a key component in this effort to ensure the safe transportation of hazardous materials.

The results of Operation Warp Speed to develop and provide COVID-19 vaccines to the masses will test manufacturers, suppliers, shippers, and logistics organizations as they safely transport and store millions of COVID-19 vaccine doses. Air Cargo is expected to take on the brunt of the initial shipping, then ground transportation and storage will play key roles as the vaccines are shipped across the country.

The U.S. Department of Transportation has prepared the way for the safe, rapid transportation of the coronavirus disease vaccine. The Federal Motor Carrier Safety Administration’s long-standing Emergency Declaration was recently extended to support emergency transport of vaccines and medical supplies and equipment related to COVID-19.

Pfizer was the first to mass ship doses of their vaccine to the U.S. from Belgium International to Chicago O’Hare, the Wall Street Journal reported. Pfizer’s doses, awaiting U.S. FDA approval, must be kept at -94 degrees Fahrenheit long term with a very limited shelf life at normal refrigerated temperatures. The Federal Aviation Administration (FAA) gave United Airlines the go-ahead to move 15,000 pounds of dry ice per flight – more than five times what is normally permitted. 

Dry ice, classed as a hazardous material, is limited in quantities since it can lower the amount of oxygen in the air as it converts back to carbon dioxide gas. In addition to dry ice, the lithium batteries needed for temperature data loggers with each dry ice unit pose a transport and logistical challenge. American Airlines, FedEx, and DHL have rolled out temperature-monitoring systems to keep tabs on future vaccine shipments. FedEx ramped up freezer capabilities in 2009 for the H1N1 pandemic and has dry ice making machines in warehouses. UPS and Lufthansa are building “freezer farms” at airport hubs. U.S. industry and military have been pressing to create temperature-controlled opportunities.  Planes and procedures have been adjusted to increase capacity to move vaccine doses.

Adding to this complexity, many of the vaccines in development will require two doses, two to eight weeks apart. The second dose may have to “partner” with your first dose – and the second dose may need to be from the same lot. Tracking who, when and where patients were dosed will be difficult – and many groups are stepping up to tackle this segment of the complexity.

If you need help with the upcoming Hazmat regulatory changes, please contact us or call (800) 508-8034 to speak with one of our professionals.

Blog Author

Diana Ludwig, STSC
Project Manager, Security, Safety & Health
KERAMIDA Inc.

Contact Diana at dludwig@keramida.com.