PHMSA has released a 20-page guide
for businesses shipping hand sanitizer covered under temporary FDA guidance.
The US Postal Service has created a process for customers to request a special exception to the Publication 52 requirements for shipping hand sanitizer by ground and, in limited cases, domestic air. Details here
Right now, everyone is stepping up to play their part in the ongoing public health emergency related to novel coronavirus or COVID-19. As part of that effort, many businesses want to prepare alcohol-based sanitizers for public distribution or internal use, including those—like distilleries
—that are not currently licensed or registered to manufacture drugs by US FDA.
Amidst the COVID-19 public health emergency, hand sanitizers are crucial to protect health care professionals, employees, and the public. To facilitate the transport of hand sanitizers, PHMSA has released a temporary enforcement policy
for companies who are now preparing hand sanitizers under a recent FDA guidance.
Because hand sanitizers are mostly alcohol, up to 80% typically, they are regulated as flammable liquids according to the US DOT’s Hazardous Materials Regulations (HMR).
The new PHMSA policy
provides partial and temporary relief from certain HMR requirements for highway
shipments of hand sanitizer.
These temporary reliefs do not apply to air, rail, or vessel shipments.
Temporary HMR Reliefs for Shipping Hand Sanitizer
The PHMSA guidance lists two sets of procedures to follow, one for smaller shipments and one for larger shipments.
For all shipments covered by this policy, PHMSA requires that:
- Packages contain hand sanitizer containing either ethyl alcohol or isopropyl alcohol at a concentration not to exceed 80%; and
- Packagings are leak tight and securely closed, secured against shifting, and protected against damage.
The guidance also lays out requirements for different quantities of hand sanitizer. The greatest relief is provided for quantities of 8 gallons or less, but packagings of up to 119 gallons
can qualify for relief when the applicable procedures are followed.
See PHMSA’s full temporary enforcement policy here.
PHMSA’s issued its temporary enforcement policy on April 2. The policy remains in effect for 3 months or until the public health emergency ends, whichever comes first.
Transport Canada’s TDG Certificate for Hand Sanitizer
Transport Canada released a similar policy on April 3, in the form of a Temporary Certificate for hand sanitizer producers who may not have the training or resources to comply with Canada’s Transportation of Dangerous Goods Act
or TDG Act.
The certificate provides general conditions for handling and offering hand sanitizer for transport.
Transport Canada’s certificate lists distinct requirements for three quantities of hand sanitizer: 5 liters or less, greater than 5 liters and less than 30 liters, and 30 liters to 450 liters.
Read Transport Canada’s Certificate here.
What’s In FDA’s Guidance?
The FDA guidance document lays out non-binding recommendations related to product ingredients, conditions of preparation, labeling, registering with FDA, and more.
You can read the full FDA guidance here: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry
Online Hazmat Training: Live or Self Paced
Join a full time Lion instructor for an engaging hazardous materials learning experience when Lion presents the Recurrent Hazmat Ground Shipper Certification Webinar
on April 14
, May 7
, or June 2.
See the full 2020 schedule.
This one-day instructor-led webinar guides you through the latest updates to the 49 CFR Hazardous Materials Regulations (HMR). Join us to develop in-depth hazmat shipping expertise. This course is designed to help meet US DOT PHMSA's hazmat training mandate at 49 CFR 172.704.
Or learn at your own pace with a convenient online course. Lion's courses are packed with interactive exercises and robust resources that enrich your online learning experience and help you retain more of what you learn.
Hazmat Ground Shipper Certification
Recurrent Hazmat Ground Shipper Certification