An important update on PPE Exports, May 2021

mask

Since the onset of the COVID-19 pandemic in 2020,  FEMA has issued out their regulations on what is permitted to be exported from the USA and the process that needs to be followed. And as we have shifted further into 2021, updates on what is permitted for export have also shifted.

On May 19th, 2021 FEMA loosened some of the previous restrictive PPE materials for exports from the USA.  It is important to take note that FEMA still has placed export controls on items that are important to the US that deals with the current pandemic.

FEMA has updated the list of restricted items as of May 19, 2021.

Effective immediately, the following are no longer restricted from export under FEMA’s Temporary Final Rule (TFR):

  • Industrial N95 Respirators, including devices that are currently NIOSH approved for use in healthcare settings under an Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA)
  • PPE Surgical Masks, as described by 21 CFR 878.4040, including masks that cover the user’s nose and mouth providing a physical barrier to fluids and particular materials, that meet fluid barrier protection standards pursuant to: ASTM F 1862; and Class I or Class II flammability tests under CPSC CS 191-53, NFPA Standard 702-1980, or UL 2154 standards
  • Piston syringes that allow for the controlled and precise flow of liquid as described by 21 CFR 880.5860, that are compliant with ISO 7886-1:2017 and use only Current Good Manufacturing Practices (CGMP) processes; or
  • Hypodermic single lumen needles that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act, Pub. L. 106-430, 114 Stat. 1901 (Nov. 6, 2000).

 

The review and restriction from export under FEMA’s TFR remains unchanged for these items:

  • Surgical N95 Respirators, that are single-use, disposable respiratory protective devices used in a healthcare setting that are worn by healthcare personnel during procedures to protect both the patient and HCP from the transfer of microorganisms, body fluids, and particulate material at an N95 filtration efficiency level per 42 CFR 84.181.
  • PPE Nitrile Gloves, specifically those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such nitrile gloves intended for the same purposes.
  • Level 3 and 4 Surgical Gowns and Surgical Isolation Gowns that meet all of the requirements in ANSI/AAMI PB70 and ASTM F2407-06 and are classified by Surgical Gown Barrier Performance based on AAMI PB70

 

For US companies that would like to export their PPE supplies to their employees outside the US, the exception that permits the export still exists however, you still need to follow the guidance that has been in place since April 2020. This includes the submission of a letter to FEMA seeking approval and of course, having received the official approval back from FEMA.

If you are a manufacturer or distributor of one of the remaining covered items under the TFR, and believe you have a surplus you may request an exemption due to a surplus of materials. This is only required for the three covered items remaining, surgical N95 Respirators, PPE Nitrile Gloves, or Level 3 and Level 4 Surgical Gowns and Surgical Isolation Gowns. You will be asked to demonstrate a good-faith and unsuccessful attempt to sell the material to the domestic market.

Should you have any questions regarding the approval steps or products that are covered under this temporary regulation please do not hesitate to contact me.