November 6, 2020

New labeling law in Mexico covers clothing but snares respirator.

On Oct. 1 Mexico’s Secretary of the Economy removed three long-standing labeling exemptions from various regulatory requirements known as Normas Oficiales Mexicanas, or NOMs. The result? Some PPE is being held at the border and not allowed into the country because of labeling.

PPE is being snagged by NOM-004 — a textile labeling law that covers household goods and clothing.  However, it is being interpreted to cover PPE such as filtering facepiece respirators (N95s). 

Department of Commerce staff members in Mexico have asked US Ambassador to Mexico Christopher Landau bring this to the attention of his counterparts.  While PPE is on the agenda for high-level discussions, a vast number of other products have also been caught by the Oct. 1 move. 

Have your products been held at the border because of labeling issues related to NOM-004?  If so, please contact Dan Glucksman. ISEA is preparing related actions on this.

Reminder on HTS Codes for Respirators

At one point, it seemed this action was the result of a new Harmonized Tariff number specifically for disposable filtering facepiece respirators.  The new Harmonized Tariff number for disposable N95 filtering facepiece respirators (FFRs) is 6307.90.9845.  The old HTS code for respirators was 6307.90.9889.  For more on this see This is item #12 on page 10 of this USTR announcement

FDA and USTR told to take COVID response items out of international trade agreements.

A range of COVID-19-response actions are called for in Executive Order 13944, “Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs Are Made in the United States.”

In this Order, the President tells FDA to create a list of Essential Medicines, Medical Countermeasures, and Critical Inputs.  The E.O. instructs the U.S. Trade Representative, in Sec. (d), to use the list to “…modify United States Federal procurement product coverage under all relevant Free Trade Agreements and the World Trade Organization Agreement on Government Procurement to exclude coverage of” the FDA-listed items. 

The list includes surgical respirators, and latex, vinyl and guayle-based gloves, and more.  See page six of the list for PPE. Read the FDA list here.

What does this mean?  It means the system where governments treat each others’ products as domestic – think: international buying group – will no longer include US products. Products on the FDA list will become more expensive as they won’t be included in tariff-reducing trade deals. 

While the aim is to increase U.S. production, it remains to be seen if this action will spur enough US production to meet COVID-19’s demands.

Finally, FDA is taking comments, but with no deadline and the list already created, the impact is likely to be scant.

New ISEA to lead coalition seeks to amplify voices on COVID-19 & preparedness policies.

ISEA has invited other like-minded associations to form a coalition to amplify each group’s voice in calling for better public health emergency preparedness in the future. 

Two immediate goals are (a) to call for a more data-driven demand picture and (b) deeper public-private partnerships so that the federal government will not need to seek PPE production numbers in the midst of a crisis.

Associations currently considering partnerships include those that represent occupational health and industrial hygiene professionals, medical PPE distributors, and end users.

If you would like additional information on any of these items or other issues impacting your company, please contact Dan Glucksman at or at 703-795-6064.