PHMSA Extends COVID Hand Sanitizer Policy for Already-Packed Product
PHMSA extended the reliefs for already-packaged product because some hand sanitizers manufactured and packaged under the Notice of Enforcement Discretion have not yet been delivered to end users.
Hand sanitizers manufactured or packaged after October 31, 2020 are subject to all applicable Hazardous Materials Regulations (HMR). The reinstated policy is effective until March 31, 2021.
PHMSA Notice of Reinstatement and Extension of Enforcement Policy Regarding Hand Sanitizers
Update 06/24/20: Today PHMSA extended through October 31, 2020 its temporary relief from certain hazmat regulations for ground shipments of hand sanitizer. The extension notice also adds rail transportation to the policy, which previously applied to highway shipments only.
Update 04/10/20: PHMSA revised its temporary enforcement policy for alcohol-based hand sanitizers to give shippers more flexibility. The revised notice provides alternate package marking options and clarifies that shippers are not required to register with PHMSA at this time if the are only shipping/transporting product covered by the policy.
Update 04/03/2020: PHMSA released a 20-page guide for businesses shipping hand sanitizer covered under temporary FDA guidance.
Also, the US Postal Service (USPS) 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. USPS Policy
Original text posted April 2, 2020
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.
*On 6/24/20, PHMSA added rail transport to the policy and extended the reliefs through October 31, 2020.
Temporary HMR Reliefs for Shipping Hand SanitizerThe 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.
See PHMSA’s full temporary enforcement policy here (Revised 04/10/20).
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 SanitizerTransport 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
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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.
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